United States
ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require a return of a mask with magnets unless the patient is contraindicated. All ResMed masks containing magnets are safe when used in accordance with the Field Safety Notice and updated Instructions for Use in the guides of affected masks. ResMed masks with magnets were distributed nationwide and globally from 2014 to November 2023. ResMed has submitted five reports of serious harm (medical intervention/hospitalization) that were potentially related to magnetic interference of a mask with a magnet with an implanted device to relevant regulatory authorities. To date, no permanent injuries or deaths have been reported.
A patient is contraindicated where they, or anyone in close physical contact while using the mask, have the following:
- Active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
- Metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye).
Patients using the masks with magnets or anyone in close physical contact with mask magnets should keep the magnets at a safe distance of 6 inches (150 mm) away from implants or medical devices that may be adversely impacted by magnetic interference. Refer to the ResMed Magnet Update website for more information about the updates issued to contraindications and warning labels.
ResMed is notifying affected customers and guiding specific actions. ResMed has provided a patient letter to healthcare providers that includes additional information regarding the contraindications and warnings for patients with the affected medical implants or devices. Patients should consult their physician and/or manufacturer of their implant or other medical device if they require additional information on the potential adverse effects of magnetic fields for their device.
For patients who, or anyone in close physical contact, do not have a contraindicated device, no action is needed.
The impacted Mask with Magnet product(s) can be identified by the model number: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i on the cushion or frame of the masks. ResMed voluntarily updated its contraindications and warning labels in response to new information obtained through post-market surveillance and industry practices.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: ResMed
Brand name: ResMed
Product recalled: Masks with magnets
Reason of the recall: Potential for magnetic interference near certain implants and medical devices
FDA Recall date: December 21, 2023
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resmed-notifies-customers-about-updated-instructions-and-labeling-masks-magnets-due-potential
