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The U.S. Food & Drug Administration (FDA) warns patients, caregivers, and health care providers that Philips Respironics (Philips) recalled 17 million CPAP and BiPAP masks used by individuals with sleep apnea. The FDA states that the mask magnets in the products can interfere with “implanted metallic devices” such as pacemakers or neurostimulators that can cause potential injuries or death when used.
The recalled CPAP and BiPAP masks include:
- Philips Respironics Amara View Full Face Mask
- Philips Respironics DreamWisp Nasal Mask
- Philips Respironics DreamWear Full Face Mask
- Philips Respironics Wisp and Wisp Youth Nasal Mask
- Philips Respironics Therapy Mask 3100 NC/SP
The masks may be continued to be used if patients or those near them don’t have metallic implants. If you are currently using a recalled mask, the FDA suggests you:
- Stop using the mask
- Consult with your health care provider to determine if another mask can be used for therapy in the meantime.
- Ensure the recalled mask is kept at least 6 inches away from metallic medical implants and medical devices
As of August 30, 2022, Philips reported 14 patients who have stated the mask’s magnets may have affected their medical devices. The FDA described several injuries, including pacemaker failure leading to a replacement, pacemaker interference, and cognitive issues. No deaths have been linked to the recall, but the announcement said fatal outcomes are possible.
The FDA reported that any implanted medical device containing metal parts may malfunction when in proximity to magnets in the recalled lists of masks. The magnets may interfere with devices such as:
- Hearing implants
- Aneurysm clips
- Embolic coils
- Cerebral spinal fluid shunts
- Insulin pumps
- Implantable cardioverter defibrillators
- Magnetic dentures
- Metallic stents
- Magnetic gastrointestinal clips
- Some joint replacements
Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443 for more information about non-magnetic options.
This recall is unrelated to the announcement last year involving the recall of Philips’s sleep apnea machines, which was caused by the risk of inhaling the breakdown of polyester foam embedded in millions of the support devices. Philips aims to complete the repair and replacement program for the majority of registered patients by December 2022.