The FDA today issued a notice confirming that a recall of Philips (NYSE:PHG) Respironics face masks is Class I, the most serious kind.
Last month, Philips provided an update on an issue with its CPAP and BiPap masks. The Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. The devices could negatively interact with implantable, metallic medical devices.
Respironics has distributed more than 17 million masks containing magnetic clips. As of Aug. 30, the company received 14 reports suggesting that the maks may have impacted implanted devices. The affected masks include the Amara View full face mask, the DreamWisp nasal mask, the DreamWear full face mask, the Wisp and Wisp Youth nasal mask and the Therapy Mask 3100 NC/SP.
According to the FDA, Philips recalled nearly 18.7 million units in the U.S. since initiating the recall on Aug. 2. It distributed the devices between Jan. 1, 2015, and Sept. 9, 2022. As of Sept. 9, Philips received 43 complaints. Fourteen of those represented serious injuries associated with the issue. It received no reports of associated deaths.
More about the recall
Patients received instructions to stop using the affected masks if the implant/device is contraindicated against the magnets. They should consult physicians to determine if it’s possible to use another mask for their therapy. In the meantime, they should switch to a non-magnetic mask if available.
Patients may continue to use the masks according to Philips’ 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.
Reports of problems included suggestions of pacemaker interference, pacemaker failure leading to replacement, the need of shunt adjustment, resetting of an automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.
The masks include magnets with a magnetic field strength of 400 mT, Philips said in the initial recall notice. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 in. (approximately 15 cm) away from any other medical implants or medical devices potentially impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.
“We have stepped up our actions to further improve patient safety and quality, and we have taken the initiative to further strengthen the warnings and add contraindications specifically related to the magnetic headgear clips in certain of our sleep therapy masks that are commonly used in the sleep therapy devices industry,” said David Ferguson, business leader for Philips Respironics, in a prepared statement at the time. He added that the company is launching a broad awareness and education campaign regarding the safety of masks containing magnetic headgear clips.
Continued troubles at Philips Respironics
Philips Respironics has long been handling a massive, deadly recall of CPAP and BiPAP ventilators and other respiratory devices. It also held talks with federal prosecutors over its handling of the recall. Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcinogenic effects for the use
In September, Philips Respironics settled with the U.S. Department of Justice for $24.8 million over kickback allegations.
Philips already spent a year out of the respiratory devices market for due to the recall. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is recently became CEO.
Implanted devices that may be affected:
- Pacemakers
- Implantable cardioverter defibrillators (ICDs)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts, for example, ventriculo peritoneal (VP) shunts
- 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 (e.g., 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 brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., 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