Contains Nonbinding Recommendations 
Intravascular Catheters, Wires, and 
Delivery Systems with Lubricious 
Coatings - Labeling Considerations 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on October 10, 2019. 
For questions about this document, contact OHT2:  Office of Cardiovascular Devices at (301) 
796-7000 or OHT5:  Office of Neurological and Physical Medicine Devices at (301) 796-6610. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
1  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852.  Identify all comments with the docket number FDA-2018-D-1774. Comments may not 
be acted upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet.  You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
16016 and complete title of the guidance in the request. 
2 Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ............................................................................................................................................ 4 
II.  Background ............................................................................................................................................ 5 
III.  Scope ...................................................................................................................................................... 6 
IV. Recommended Labeling Considerations ................................................................................................ 8 
A. Device Description ............................................................................................................................ 8 
B. Indications for Use Statement ........................................................................................................... 9 
C. Warnings, Precautions and Preparation Steps ................................................................................... 9 
D. Potential Adverse Events ................................................................................................................ 12 
3 Contains Nonbinding Recommendations 
Intravascular Catheters, Wires, and 
Delivery Systems with Lubricious 
Coatings - Labeling Considerations 
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I.  Introduction 
This guidance document addresses labeling considerations for devices containing lubricious 
coatings used in the vasculature. The purpose of this guidance document is to provide 
recommendations for information to be included in the device labeling, as submitted in 
premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and 
Class II devices, to enhance the consistency of coating-related information across these product 
areas, as well as to promote the safe use of these devices in the clinical setting. Medical devices 
such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and 
implant delivery systems are commonly used during minimally invasive diagnostic and 
therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems. 
These devices often have hydrophilic and/or hydrophobic lubricious coatings (e.g., 
polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone) to reduce friction 
between devices, and between device(s) and blood vessels. It is commonly believed that these
coatings may offer physicians greater maneuverability and may result in less trauma to blood 
vessels for patients.
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
4 Contains Nonbinding Recommendations 
II.  Background 
Hydrophilic and/or hydrophobic coated devices have been used for more than 20 years in 
minimally invasive diagnostic and therapeutic cerebrovascular, cardiovascular, and peripheral 
vascular procedures. Both of these types of coatings decrease friction between the device and 
blood vessels. These devices facilitate the ability for physicians to provide minimally invasive 
treatment options to patients. 
Although these devices may offer patient benefits, recent evidence indicates that the coating may 
separate from intravascular devices in some circumstances. The FDA has received and analyzed 
information concerning serious adverse events associated with hydrophilic and/or hydrophobic 
coatings separating (e.g., peeling, flaking, shedding, delaminating, sloughing off) from 
intravascular medical devices. This information has included voluntary recalls of guidewires, 
sheaths, retrieval devices, and embolization device delivery wires, as well as Medical Device 
Reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings from medical 
devices such as guidewires, catheters, and introducers that have been used for cerebrovascular, 
cardiovascular, and peripheral vascular procedures. 
The FDA has also evaluated other relevant information, including peer-reviewed medical 
literature1,2,3,4 and physician surveys5. Serious adverse events reported in these MDRs and in the 
medical literature include pulmonary embolism, pulmonary infarction, myocardial embolism, 
myocardial infarction, embolic stroke, tissue necrosis, and death. Serious injuries associated with 
the peeling of coatings reported in MDRs included the persistence of coating fragments in 
patients, some of which required surgical intervention to mitigate the consequences, adverse 
tissue reactions, and thromboses. Additional information related to these analyses may be found 
in the FDA Safety Communication for Lubricious Coating Separation from Intravascular 
Medical Devices issued on November 23, 2015 (http://wayback.archive-
it.org/7993/20170722215712/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/uc
m473794.htm). This safety communication was issued to make health care providers aware of 
the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices 
                                                          
1 Grundeken MJ, Li X, Kurpershoek E, Kramer MC, Vink A, Piek JJ, Tijssen JGP, Kock KT, Wykrzykowska JJ, de Winter RJ, 
van der Wal AC, Distal Embolization of Hydrophilic-Coating Material From Coronary Guidewires After Percutaneous Coronary 
Interventions. Circulation: Cardiovascular Interventions, 2015; 8(2):e001816. 
2 Hu YC, Deshmukh VR, Albuquerque FC, Fiorella D, Nixon RR, Heck DH, Barnwell SL, McDougall CG, Histopathological 
assessment of fatal ipsilateral intraparenchymal hemorrhages after the treatment of supraclinoid aneurysms with the Pipeline 
Embolization Device. Journal of Neurosurgery, 2014; 120(2); 365-374. 
3 Mehta RI, Mehta RI, Choi JM, Mukherjee A, Castellani RJ, Hydrophilic polymer embolism and associated vasculopathy of the 
lung: prevalence in a retrospective autopsy study. Human Pathology, 2014; 46(2): 191-201. 
4 Mehta RI, Mehta RI, Chung YC, Hydrophilic polymer embolism: an underrecognized iatrogenic cause of ischemia, 
inflammation, and coagulopathy. Human Pathology, 2015; 46(3): 488-489. 
5 MedSun Newsletter.  (2015, Oct). Hydrophilic Coating and Hydrophobic Coating on Medical Devices Used in the 
Vasculature. 15(2), 3-11. (http://wayback.archive-
it.org/7993/20170112002248/http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Ne
wsletters/UCM464550.pdf) 
5 Contains Nonbinding Recommendations 
and potentially cause serious injuries to patients. The safety communication also includes 
information physicians may consider to reduce the potential of adverse events. 
The FDA has not concluded that any specific manufacturer or brand of these devices is 
associated with higher risks than others. The cause of coating separation is multifactorial, and 
can be associated with factors including device design, device manufacturing (including 
formulation and raw material sourcing) and clinical use. Current FDA analysis suggests that 
clinical use-related issues may be mitigated through proper device selection, preparation, 
adequate premarket testing and other labeling considerations that are addressed within this 
guidance document. For recommendations on premarket testing, please refer to the FDA 
guidance titled Class II Special Controls Guidance Document for Certain Percutaneous 
Transluminal Coronary Angioplasty (PTCA) Catheters, 6 the FDA guidance titled Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated 
Delivery Systems7, and the guidance titled Performance Tests and Recommended Labeling for 
Coronary, Peripheral, and Neurovascular Guidewires.8  
III.  Scope 
This guidance document provides labeling recommendations for both Class III and Class II 
devices such as intravascular catheters, wires, and delivery systems with lubricious coatings used 
in the vasculature.  Due to higher risks that are associated with use of these devices in the neuro-, 
coronary, and peripheral vasculature, FDA has focused the scope of this guidance on devices 
used in those vascular regions, although some of these considerations could be applicable to 
devices with similar coatings used in other types of interventional procedures. The scope of this 
guidance document includes a variety of devices and product codes including the following 
Class II and Class III devices (Tables 1 and 2, respectively).  The devices are listed in 
alphabetical order (not risk- or event-based). 
Table 1. Class II Devices Within Scope of Guidance 
Product Code  Product Code Name  Regulation 
Number 
DQO  Catheter, Intravascular, Diagnostic  870.1200 
DQX  Wire, Guide, Catheter  870.1330 
DQY  Percutaneous Catheter  870.1250 
DSP  System, Balloon, Intra-Aortic and Control  870.3535 
DXE  Catheter, Embolectomy  870.5150 
DXO  Transducer, Pressure, Catheter Tip  870.2870 
DYB  Introducer, Catheter  870.1340 
                                                          
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/class-ii-special-controls-guidance-
document-certain-percutaneous-transluminal-coronary-angioplasty 
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-engineering-tests-and-
recommended-labeling-intravascular-stents-and-associated-delivery 
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/coronary-peripheral-and-
neurovascular-guidewires-performance-tests-and-recommended-labeling 
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Product Code  Product Code Name  Regulation 
Number 
FOZ  Catheter, Intravascular, Therapeutic, Short- 880.5200 
Term Less Than 30 Days 
HCG  Device, Neurovascular Embolization  882.5950 
KRA  Catheter, Continuous Flush  870.1210 
LIT  Catheter, Angioplasty, Peripheral,  870.1250 
Transluminal 
LJS  Catheter, Intravascular, Therapeutic, Long- 880.5970 
Term Greater Than 30 Days 
LJT  Port & Catheter, Implanted, Subcutaneous,  880.5965 
Intravascular 
LOX  Catheters, Transluminal Coronary  870.5100 
Angioplasty, Percutaneous 
MCW  Catheter, Peripheral, Atherectomy  870.4875 
MJN  Catheter, Intravascular Occluding, Temporary  870.4450 
MOF  Guide, Wire, Catheter, Neurovasculature  870.1330 
NDQ  System, Catheter or Guidewire, Steerable  870.1290 
(Magnetic) 
NFA  Temporary Coronary Saphenous Vein Bypass  870.1250 
Graft Catheter for Embolic Protection 
NRY  Catheter, Thrombus Retriever  870.1250 
NTE  Temporary Carotid Catheter for Embolic  870.1250 
Capture 
NVM  Catheter, Angioplasty, Peripheral,  870.1250 
Transluminal, Dual-Balloon 
POL  Neurovascular Mechanical Thrombectomy  882.5600 
Device for Acute Ischemic Stroke Treatment 
Although the product codes listed above are current as of the date of issuance of this guidance, 
new product codes may be created over time for vascular medical devices regulated under the 
classification regulations identified and fall within the scope of this guidance.  We recommend 
that you contact OHT2:  Office of Cardiovascular Devices or OHT5:  Office of Neurological and 
Physical Medicine Devices if you are unsure whether this guidance applies to your device or 
product code if it is not already captured in this guidance. 
Table 2.  Class III Devices Within Scope of Guidance 
Product Code  Product Code Name 
MAF  Stent, Coronary 
MIH  System, Endovascular Graft, Aortic Aneurysm Treatment 
MLV  Transcatheter Septal Occluder 
MOM  System, Hemodynamic, Implantable 
NIM  Stent, Carotid 
NIN  Stent, Renal 
NIO  Stent, Iliac 
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Product Code  Product Code Name 
NIP  Stent, Superficial Femoral Artery 
NJE  Intracranial Neurovascular Stent 
NKM  Mitral Valve Repair Devices 
NPT  Aortic Valve, Prosthesis, Percutaneously Delivered 
NWX  Catheter, Percutaneous Transluminal Coronary Angioplasty 
(PTCA), Cutting/Scoring 
ONU  Drug-Eluting Peripheral Transluminal Angioplasty Catheter 
OUT  Intracranial Aneurysm Flow Diverter 
PFV  System, Endovascular Graft, Arteriovenous (AV) Dialysis Access 
Circuit Stenosis Treatment 
QCA  Intracranial Coil-Assist Stent 
IV.  Recommended Labeling Considerations 
This guidance is intended to help develop labeling that will provide information for use and other 
information in accordance with 21 CFR Part 801.109 and other applicable requirements in 21 
CFR 801.  FDA recommends including the following information in the device labeling for 
intravascular devices with lubricious coatings. We intend for this information to supplement and 
enhance the information that is already in the device labeling for these device types, and do not 
intend for it to replace information already included in the labeling. Since these 
recommendations are based on known safety issues, FDA recommends that this information be 
considered for inclusion as current product labeling is updated, and that labeling included as part 
of future premarket submissions for intravascular devices with lubricious coatings incorporate 
the recommendations. For currently 510(k)-cleared intravascular devices with lubricous coatings, 
please refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing 
Device,9 which provides guidance to 510(k) holders on deciding when to submit a 510(k) for a 
change to an existing device. 
A.  Device Description 
In addition to the device description currently provided for the device, the device 
labeling for a coated device should include a statement to identify that the device 
is coated, as well as a brief description (e.g., hydrophilic, hydrophobic) of the 
coating, its location on the device (e.g., proximal or distal end), the length of the 
coating, and its purpose. 
We recommend the device description prominently note the presence of the 
coating and refer the user to additional critical information. 
                                                          
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device 
8 Contains Nonbinding Recommendations 
If the device is intended for use with specific ancillary device(s) dimension(s), we 
recommend specifying this information because size mismatch may result in 
coating damage and adverse events.   
B.  Indications for Use Statement 
All indications for use described in the labeling should be supported by 
information in the premarket submission.  For intravascular devices, this includes 
identifying any specific regions of the vasculature for which the device is cleared 
or approved for use. 
C.  Warnings, Precautions and Preparation Steps 
Many devices are designed, labeled, and indicated for specific uses. FDA 
acknowledges that the specific warnings and precautions may depend on the 
specific design and intended use of the device. For example, the coating and 
performance of a device intended to be used in the peripheral vasculature may be 
different than a device intended to be used in the cerebral vasculature. If 
information regarding safety is not available or has not been established for 
indications other than those specified in the regulatory submission, it may be 
appropriate to consider the inclusion of a precaution statement reflecting such. For 
example: The safety and effectiveness of the coated device has not been 
established, or is unknown, in vascular regions other than those specifically 
indicated. 
In addition, we recommend that the labeling include any other specific 
considerations such as device compatibility, storage conditions, specific 
preparation steps, and any appropriate troubleshooting or tips that should be 
conveyed to the device user in order to enhance the safe use of the device. Table 1 
provides a listing of the information suggested for inclusion. 
The preparation steps should include information that will guide the user in a 
clinical setting. Some of these items may be included as warnings or precautions 
in the instructions for use or on the outer label. Please refer to Table 1 for specific 
recommendations to consider when developing the labeling. If you believe one or 
more of these considerations are not applicable to your device, we recommend 
you provide a brief rationale in your premarket submission. We recommend that 
you include any additional warnings and precautions not identified below that you 
determine are necessary to promote the safe use of the device based on your 
device design and intended use. 
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Table 3. Recommendations and Items to Consider When Developing the 
Labeling 
Warnings and Precautions 
a.  Any instructions, warnings, or precautions necessary to ensure the 
safe and effective use of the lubricious coating should be addressed. 
b.  We recommend including a warning, such as: Warning: Failure to 
abide by the warnings in this labeling might result in damage to the 
device coating, which may necessitate intervention or result in 
serious adverse events. 
c.  We recommend a warning against reuse or re-sterilization of the 
device, which could damage the coating and affect coating 
performance, for example, This device is intended for single use. 
Do not reuse or re-sterilize. 
d.  If applicable, we recommend specification of the appropriate 
duration for pre-conditioning. If applicable, include a precaution 
against soaking for extended periods when the device is not in use. 
If the coating integrity or performance could be negatively 
impacted by extended soaking or pre-conditioning, we recommend 
alerting the user of the maximum soaking or pre-conditioning time. 
For example, alert the user to avoid pre-soaking devices for longer 
than instructed, as this may impact the coating performance. 
e.  If applicable, we recommend a specification of any known 
incompatibility with specific media or solvents (e.g., alcohol or 
antiseptic). If the coating integrity or performance could be 
negatively impacted by preparation with incompatible media, we 
recommend including a precaution in the labeling alerting the user. 
f.  If applicable, we recommend inclusion of a warning or precaution 
regarding the swelling behavior of the coating when exposed to 
aqueous media and any impact on device use. 
g.  We recommend that the labeling instruct and warn users to use 
caution when manipulating, advancing and/or withdrawing these 
devices through needles, metal cannulas, stents, or other devices 
with sharp edges, or through tortuous or calcified blood vessels. 
Manipulation, advancement, and/or withdrawal past sharp or 
beveled edges may result in destruction and/or separation of the 
outer coating, which may lead to clinical adverse events, resulting 
in coating material remaining in the vasculature or device damage. 
This may result in adverse events (section D below) requiring 
additional intervention. 
Preparation Steps and Instructions for Use 
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Table 3. Recommendations and Items to Consider When Developing the 
Labeling 
h.  If the device is anticipated to be used with other devices and/or 
accessories, sufficient information to identify a safe combination of 
devices and/or procedure-specific components should be included 
due to abrasion between devices. 
1)  For example, it is important that the user is informed of key 
device dimensions (e.g., French size, inner diameter, outer 
diameter) and potential compatibility issues with other 
devices based on these key dimensions. A tight fit between 
the subject device and ancillary devices may exacerbate 
frictional forces during use which could contribute to 
unanticipated coating loss such as peeling, flaking, 
shedding, delamination, or sloughing off. 
2)  If the device coating swells when exposed to aqueous media 
(e.g., saline, heparinized saline), which could impact its use 
with other devices, we recommend communicating this in 
the instructions for use. 
i.  We recommend that any special storage and/or handling conditions 
are described. For example, any storage conditions needed to 
ensure the integrity of the coating over the labeled shelf-life should 
be described (e.g., limits related to light exposure, temperature, 
and/or relative humidity during storage, expiration date). 
j.  The devices expiration date should be included on the package 
label. The date should be presented in a format consistent with 21 
CFR 801.18. 
k.  We recommend the specification of appropriate conditioning media 
(e.g., normal saline, sterile water, or heparinized saline) prior to and 
during clinical use.It should be stated when solutions may not be 
interchangeable, for instance if different media could affect the 
hydrophilic and/or hydrophobic coatings differently; this is 
important because coatings may vary from the proximal to the 
distal end on a single device.
l.  We recommend that any practices that should be avoided during 
preparation or device use that could result in misuse scenarios or 
coating damage be identified. Some examples may include: 
1)  Avoid wiping the device with dry gauze as this may damage 
the device coating. 
2)  Avoid excessive wiping of the coated device. 
3)  Avoid using alcohol, antiseptic solutions, or other solvents 
to pre-treat the device because this may cause unpredictable 
changes in the coating which could affect the device safety 
and performance.
4)  Avoid pre-soaking devices for longer than instructed, as this 
may impact the coating performance.
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Table 3. Recommendations and Items to Consider When Developing the 
Labeling 
m.  If the distal tip of the device is flexible and designed to be shaped 
by the physician, the labeling should instruct the user of appropriate 
shape configurations and shaping techniques. If applicable, it 
should also inform the user that attempting to alter the shape of 
devices by bending, twisting, or similar methods beyond instructed 
methods may compromise the coating integrity and that damage to 
the coating may not always be noticeable to the naked eye.
n.  In the event that the device should not move freely, it may be 
appropriate to recommend that the user determine the source of 
resistance, exercise caution when removing the device and/or other 
components as a unit, and exchange the device for a new one to 
complete the procedure. 
For more information on warnings and precautions, please refer to the Device 
Labeling Guidance #G91-1 (blue book memo) (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/device-labeling-guidance-g91-1-
blue-book-memo). 
D.  Potential Adverse Events 
Potential adverse events that could be attributed to coating loss should be 
described in the labeling. FDA acknowledges that the specific adverse events may 
depend on the specific design and intended use of the device. Such adverse events 
may include, but are not limited to: 
  Sterile inflammation or granulomas at the access site 
  Pulmonary embolism 
  Pulmonary infarct 
  Myocardial embolism 
  Myocardial infarct 
  Embolic stroke 
  Cerebral infarct 
  Additional surgical intervention 
  Tissue necrosis, transient or long-lasting 
  Death 
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