Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem.
Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.
The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
For a company that dominates the market for devices designed to improve breathing during sleep, Royal Philips NV has had the devil of time catching its own breath over the last 15 months as it has issued wave after wave of recalls.
A variety of positive airway pressure (PAP) devices made by Philips Respironics Inc. have been subject to a lengthy and expensive recall due to the use of a problematic material in acoustic insulation foam, but now the company has a new headache in connection with its offerings. The FDA said this latest safety notification is due to the possible presence of a plastic that is contaminated with a non-compatible material, although this recall affects fewer than 400 units.
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.