A recall was issued on 17 million sleep apnea masks manufactured by Philips that contain magnetic clips. Those clips have reportedly interfered with medical metallic implants or objects in the body such as pacemakers, cardioverter defibrillators and neurostimulators.
The recalled CPAP and BiPAP (also known as Bilevel PAP) therapy clips are used to attach the headgear straps to the mask. However, new warnings say that the masks should not be used if the patient or household members, caregivers or bed partners have a metallic medical implant.
Philips has received 14 reports of patients who said the mask’s magnets may have affected their medical devices, causing problems such as pacemaker failure, defibrillator shutoff, change in heartbeats and cognitive issues. No deaths have been linked to the recall, but the announcement said that fatal outcomes are possible.
The recalled masks include the Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and the Therapy Mask 3100 NC/SP.
This recall is unrelated to an announcement last year involving Philips sleep apnea machines with foam that patients were at risk of inhaling.
Advice to consumers
The recalled masks may continue to be used when patients or those near them do not have metallic implants, Philips said in its updated instructions and product labels.
The recall is not intended to replace all masks with magnets that are in use. Instead, it is intended to alert consumers that the previous warnings on the devices have been strengthened, noting that the magnets may interfere with metallic implants.
“These masks are safe and may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body,” said Philips.
Meanwhile, other medical implants or medical devices that may be affected by magnets should remain at least 6 inches away from the recalled sleep apnea masks.
Those who use one of the affected masks or live with someone who has a medical implant listed below should consult their physician to determine if another mask can be used for therapy. Meanwhile, these patients should switch to a nonmagnetic mask if available.
Anyone with questions may contact Philips Respironics customer service at 800-345-6443 from Monday through Friday, 8:30 a.m. ET to 8 p.m. ET, or call the Durable Medical Equipment (DME) provider who supplied their mask. Additional questions may be answered on Philips’ FAQ page.
Other adverse experiences related to the recalled masks should be reported to the FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, on the MedWatch Web site at fda.gov/medwatch, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852.
These metallic devices and implants may be affected by magnets in the recalled masks:
- Implantable cardioverter defibrillators (ICD)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso or higher (such as neck and head)
- Cerebral spinal fluid (CSF) shunts (ventriculoperitoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (glaucoma implants, 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 brain stem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
Aaron Kassraie writes about issues important to military veterans and their families for AARP. He also serves as a general assignment reporter. Kassraie previously covered U.S. foreign policy as a correspondent for the Kuwait News Agency’s Washington bureau and worked in news gathering for USA Today and Al Jazeera English.