Sleepnet Corp is recalling all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices.
When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious injury or death.
Sleepnet has been distributing masks with magnets worldwide since 2006, and to date, there have been no medical device reports associated with the Sleepnet masks with magnets. This is a voluntary action based on information obtained from post-market surveillance, according to a company announcement.
Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.
If a patient or anyone (such as household members, bed partners, caregivers, etc) in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets, these masks with magnets should not be used.
Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators, neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, and magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher.
Sleepnet masks with magnets are safe when used in accordance with the newly updated instructions for use, according to the company announcement. Continue using masks 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.
Sleepnet is adding a new contraindication and an updated warning to the instructions for use labeling of the affected products. This will be included in the labeling for all future production of these masks.
Adverse reactions or quality problems experienced with the use of this product may be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
