August 12, 2004

**Item: Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and
Cannula FDA Class I Recall.**

### General Information: FDA and Nellcor/Tyco have issued a Class I (most serious) recall of the Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Cannula. The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patient's airway leading to obstruction of the airway and significantly interfering with breathing and ventilation. 

**Specific Incident:** Nellcor/Tyco has received two reports in which
the cannula separation was allegedly associated with patient deaths.
This recall affects 73,355 disposable units that the company has shipped
to the U.S. and international customers over the last four years.

> Actions: 1. Patients with the affected models (see attached) should be
> contacted and arrangements made to exchange the equipment.

2.  If you have the affected devices in stock work with your materials
    management (AMMS) to make sure that a recall package has been
    received. Follow the instructions in the package to receive credit
    for the recalled products.

3.  If you have these devices in stock and did not receive a recall
    package from the company, contact Nellcor/Tyco Technical Services
    Department at 1-800-635-5267.

4.  See attached information on comparable replacements from Smiths
    Medical Bivona® to the recalled products.

**Source:** FDA and Tyco Healthcare.

# Contact: Bryanne Patail at the VA National Center for Patient Safety (NCPS) phone: (734) 930-5852.

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| ## Me                                               | ![](media/     |
| dical Device Recalls Class 1 Recall: Shiley Tracheo | image6.png){wi |
| soft Tracheostomy Tube and Disposable Inner Cannula | dth="1.5625in" |
|                                                     | he             |
|                                                     | ight="0.333333 |
|                                                     | 3333333333in"} |
+-----------------------------------------------------+----------------+

  -------------- ----- -------------------------------- -----------------------------
  **Date Recall\       July 8, 2004                     
  Initiated:**                                          

  **Product:**         Shiley Tracheosoft XLT Extended  
                       Length Tracheostomy Tube and     
                       Disposable Inner Cannula         

  **Use:**             The device is an extended length 
                       cannula (tube) with accessory    
                       components used to provide an    
                       artificial airway to assist in   
                       the treatment of a variety of    
                       respiratory diseases and airway  
                       management in adults. The tube   
                       is inserted into a tracheostomy  
                       incision in a patient's neck and 
                       trachea. The tracheostomy tube   
                       is secured in place through the  
                       tube's hub and flange assembly   
                       with the use of a holder or neck 
                       strap.                           

  **Recalling          Nellcor/Tyco Healthcare\         
  Firm:**              4280 Hacienda Drive\             
                       Pleasanton, CA 94588-2719        

  **Reason for         The outer cannula may separate   
  Recall:**            from the hub and neck flange     
                       allowing the outer cannula to    
                       travel farther into the          
                       patient's airway and             
                       significantly interfere with     
                       breathing and ventilation. This  
                       recall affects 73,355 disposable 
                       units that the firm has shipped  
                       to U.S. and international        
                       customers over the last four     
                       years.                           

  **Public             James Bonds\                     
  Contact:**           Senior Director, Regulatory      
                       Affairs\                         
                       925-463-4371\                    
                       james.bonds@tycohealthcare.com   

  **FDA                San Francisco                    
  District:**                                           

  **FDA                Failure of the tracheostomy tube 
  Comment:**           can allow the tube to migrate,   
                       leading to obstruction of the    
                       airway and subsequent lack of    
                       ventilation. Airway obstruction  
                       or failure to ventilate can lead 
                       to permanent neurological injury 
                       or death. Class I recalls are    
                       the most serious type of recall  
                       and involve situations where     
                       there is a reasonable            
                       probability that use of the      
                       product will cause serious       
                       injury or death.                 

  ** **                                                 

                                                        

                                                        
  -------------- ----- -------------------------------- -----------------------------

Pleasanton, CA -- August 6, 2004 -- On July 8, 2004, Nellcor/Tyco
Healthcare, initiated a voluntary recall of the Shiley® TracheoSoft® XLT
Extended Length Tracheostomy Tube. The Company has shipped 73,355 units
over the last four years throughout the U.S. and Canada. This product
can be used in the hospital or home-care environment to provide tracheal
access for airway management. The recall was prompted by reports of the
outer cannula separating from the swivel neck plate. While the number of
customer reports of cannula separation is very low, if this failure mode
does occur, the outer cannula could travel into the patient's airway,
potentially interfering with breathing or ventilation; which could
result in serious injury or death.

Accordingly, in the interest of patient safety, our recall extends to
all lots of the following products:

  -------------------- --------------------------------------------------
  **Model Number**     **Description**

  72110-050            Size 5, Proximal Extension, Uncuffed

  72110-060            Size 6, Proximal Extension, Uncuffed

  72110-070            Size 7, Proximal Extension, Uncuffed

  72110-080            Size 8, Proximal Extension, Uncuffed

  72120-050            Size 5, Proximal Extension, Cuffed

  72120-060            Size 6, Proximal Extension, Cuffed

  72120-070            Size 7, Proximal Extension, Cuffed

  72120-080            Size 8, Proximal Extension, Cuffed

  73110-050            Size 5, Distal Extension, Uncuffed

  73110-060            Size 6, Distal Extension, Uncuffed

  73110-070            Size 7, Distal Extension, Uncuffed

  73110-080            Size 8, Distal Extension, Uncuffed

  73120-050            Size 5, Distal Extension, Cuffed

  73120-060            Size 6, Distal Extension, Cuffed

  73120-070            Size 7, Distal Extension, Cuffed

  73120-080            Size 8, Distal Extension, Cuffed

  77100-050            Size 5, XLT, Disposable Inner Cannula

  77100-060            Size 6, XLT, Disposable Inner Cannula

  77100-070            Size 7, XLT, Disposable Inner Cannula

  77100-080            Size 8, XLT, Disposable Inner Cannula
  -------------------- --------------------------------------------------

The Company has received two reports in which the cannula separation was
allegedly associated with two patient deaths. Those TracheoSoft XLT
Tracheostomy Tubes currently in use should be exchanged, when practical,
with an alternative model at the discretion and judgment of the
patient's physician.

Institutions with affected product have received packages outlining the
recall process. As of this date, 80 percent of those customers have
responded to the recall action. The U.S. Food and Drug Administration
(FDA) and officials in other affected countries have been apprised of
this recall action.

This action does not affect any other model of Shiley tracheostomy
products. We apologize for any disruption this action may cause
physicians and their patients. Please be assured that Nellcor/Tyco
Healthcare has taken appropriate steps to prevent recurrence of this
problem and ensure patient safety.

Clinicians and patients with inquiries should contact our Technical
Services Department at **1-800-635-5267, option 3**.

**About Tyco Healthcare**\
Tyco Healthcare, a business segment of Tyco International Ltd., is a
leading manufacturer, distributor and servicer of medical devices
worldwide. Its broad portfolio includes disposable medical supplies,
monitoring equipment, medical instruments and bulk analgesic
pharmaceuticals, sold under such names as Auto Suture, Kendall,
Mallinckrodt, Nellcor, Puritan Bennett, United States Surgical,
Valleylab and others.

Updated August 9, 2004

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