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          Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety CommunicationSafety Communications Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
  
  	
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    Print**Date Issued: January 18, 2024**

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP). The recalled masks have magnets that can cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices or metallic objects in the body. The FDA classified this recall as a Class I recall, the most serious type of recall.

Potential adverse events can occur in people who use a recalled ResMed mask with magnets or in people near a person using the mask. Additionally, the recalled ResMed masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled ResMed masks.

ResMed is making replacement masks without magnets available to mask providers.

Recommendations for Patients and Caregivers

**Stop use** of the recalled mask and switch to a non-magnetic mask, if available, if you have any of the implanted metallic medical devices or metallic objects (listed below) in your body. This recommendation also applies if anyone in close physical contact with the mask has any of the listed implanted metallic medical devices or metallic objects in the body.
	Ensure the recalled mask is kept at least six inches away from the listed implanted metallic medical devices or metallic objects in the body.
	Consult with your health care provider to determine if another mask can be used for therapy and to decide if the plan for your care and treatment should change as a result of this safety issue.
	Contact your mask provider if you cannot continue to use your mask with magnets. ResMed is making replacement masks without magnets available to mask providers.
	Contact your health care provider immediately if you have any issues related to your medical device and report the issue through the FDA’s MedWatch Voluntary Reporting Form.
	If you have additional questions, contact ResMed Ltd customer service online or by phone at 1 (800) 424-0737.
	Dispose of the recalled mask if you receive an alternative mask.
	You may continue to use the recalled mask if neither you nor anyone in close physical contact with the mask have any of the implanted metallic medical devices or metallic objects listed below.Recommendations for Health Care Providers

Read and follow the recommendations for patients and care givers.
	Discuss the health risks associated with using a recalled mask with patients who may be at risk for potential injury or death due to magnets affecting the function or inducing movement of certain implanted metallic medical devices or metallic objects in the body.
	Do not prescribe use of the recalled masks on patients who have any of the implanted metallic medical devices or metallic objects in the body listed below as they may be affected by the magnets in the masks. Prescribers should also ask about any other people who may be at risk for injury or death if they are near a recalled mask.
	If you have any problems with a recalled mask or if you treat a patient who has been affected, report the issue through the FDA’s MedWatch Voluntary Reporting Form.Device Description

The recalled Airfit and AirTouch masks are worn by people using a BiPAP or CPAP machine. The masks have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66 pounds.

The recall affects the following ResMed masks with magnets:

Mask Type
			Affected MasksFull face mask
			AirFit F20, AirFit F20 for Her
			AirTouch F20, AirTouch F20 for Her
			AirFit F30
			AirFit F30iNasal mask
			AirFit N10, AirFit N10 for Her
			AirFit N20, AirFit N20 for Her
			AirTouch N20, AirTouch N20 for HerNon vented mask
			AirFit F20 NV

Unique Device Identifier (UDI)

The manufacturer has provided the unique device identifier for each recalled model of the Airfit and AirTouch masks. The location of the model name and magnets can be found in ResMed’s safety notice.

The unique device identifier helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

How do I recognize a UDI on a label?
	AccessGUDID database - Identify Your Medical Device
	Benefits of a UDI SystemYou can identify the devices affected by checking the unique device identifier (UDI), which is a unique numeric or alphanumeric code that generally includes a Device identifier (DI) that identifies the labeler and the specific version or model of a device, as well as a Production identifier (PI) that identifies additional information, which may include lot number, serial number, expiration date, and manufactured date.

Magnets Can Interfere with Certain Implanted Metallic Medical Devices and Metallic Objects in the Body

Potential adverse events can happen in people who use the ResMed mask with magnets, or in people near a person using the mask.

The magnets can potentially cause injury or death if used near people who have certain implanted metallic medical devices or metallic objects in the body, such as:

Pacemakers
	Implantable cardioverter defibrillators
	Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
	Neurostimulators, magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
	Cerebral spinal fluid shunts (such as ventriculoperitoneal shunts)
	Aneurysm clips
	Embolic coils
	Intracranial aneurysm intravascular flow disruption devices
	Metallic cranial plates, screws, burr hole covers, and bone substitute devices
	Ocular implants (such as glaucoma implants and retinal implants)
	Certain contact lenses with metal
	Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
	Dental implants
	Implantable ports and pumps (such as insulin pumps)
	Metallic splinters in the eye
	Metallic shrapnel in the bodyIf the magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body, the potential risks may include:

For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
	For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
	For pacemakers: heart block or irregular heartbeat, which may be fatal.
	For cardioverter defibrillators: may fail to shock, which may be fatal.
	For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.FDA Actions

The FDA recognizes that patients rely on these devices and is closely monitoring ResMed's actions to ensure the issue is resolved, given the impact on patients. The FDA continues to work with ResMed to ensure the company takes appropriate steps to correct the recalled devices.

The FDA is assessing the health hazard presented by use of the recalled products, reviewing the strategy ResMed proposes to address the problem, and may take additional actions as appropriate.

The FDA is also evaluating the safety of magnets that may be present in masks or similar interfaces from other manufacturers that are used in sleep medicine and that may have the potential to impact patient safety. The FDA intends to alert these manufacturers, if appropriate, and take necessary steps to address any issues that may be identified.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Data Summary

Medical Device Reports

Manufacturers, such as ResMed, are required to submit medical device reports (MDRs) when information reasonably suggests that their device may have caused or contributed to a death or serious injury or has malfunctioned and that device or a similar device they manufacture would likely cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.

Six injuries have been reported related to the use of the recalled masks. There have been no reports of deaths. The injury reports involved magnetic interference with implanted devices resulting in allegations of serious harm that required medical intervention or hospitalization. The reported devices include an implantable cardioverter defibrillator, a cochlear implant, a cerebrospinal fluid shunt, and brain and dental implants.

Although MDRs are a valuable source of information, this passive surveillance system has limitations.  The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device’s benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

                                                                                  Content current as of:
      01/18/2024
              
              
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