Tag: Recall

MINNEAPOLIS, Minn. – Inspire Medical Systems is voluntarily recalling its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy. There have been no reported injuries or death. Health care providers should:  Notify affected patients of this voluntary recall.  Schedule...

WASHINGTON – The U.S. Food and Drug Administration on June 27 highlighted updated use instructions from Philips Respironics for its BiPAP V30, BiPAP A30 and BiPAP A40 ventilators due to potential interruptions and/or loss of therapy.  Philips has updated the use instructions for the vents due to a potential failure in the ventilator inoperative alarm, which can cause therapy interruption or loss.  New instructions  If interruptions of therapy can be tolerated and...

WASHINGTON – The U.S. Food and Drug Administration has announced a recall of the Ventec Life Systems VOCSN patient breathing package (pediatric, active, oxygen, blue) for a manufacturing issue with its bonded spiral wrap. The recall, a Class I or most serious type of recall, is a correction, not a product removal. The issue: The spiral wrap detaching before or during ventilation, with the potential of compromising the structural integrity and functionality or of causing blockage, stoppage or...

WASHINGTON – Philips has submitted more than 7,000 medical device reports, including 111 reports of death, for July 1, 2023, to Sept. 30, 2023, that are associated with the breakdown or suspected breakdown of the foam used in the ventilators and BiPAP and CPAP devices included in its large recall, according to the U.S. Food and Drug Administration. Since April 2021, the company has submitted more than 116,000 MDRs, including 561 reports of death, reportedly associated with the breakdown or...

YARMOUTH, Maine – Even after enduring the roller-coaster of doing business with Philips Respironics the past few years, providers were still shocked by the company’s recent announcement that it would stop selling certain respiratory products.  Philips on Jan. 25 announced that it would discontinue selling 19 products in the U.S., including items subject to a recall, like the Trilogy 100/200/202 portable home ventilators. The company will service many of the products until Jan....

AMSTERDAM – Philips has agreed on the terms of a multi-year consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory care devices, providing clarity and a roadmap to demonstrate compliance and to restore the business, the company says.  In the U.S., Respironics will continue to service sleep and respiratory care devices already with health care providers and patients, and supply accessories (including patient...

SAN DIEGO – ResMed CEO Mick Farrell said a recall of its CPAP masks with magnets did not impact the company’s sales for the second quarter ended Dec. 31, 2023.  ResMed in November issued an urgent field safety notice to patients detailing possible interference with its AirFit and AirTouch masks and certain medical devices; the company in December then announced a voluntary global field action to update its guides. The U.S. Food and Drug Administration in January classified...

WASHINGTON – The U.S. Food and Drug Administration has classified ResMed’s recall of CPAP masks with magnets a Class I recall, the most serious type.  ResMed in November issued an urgent field safety notice to patients detailing possible interference with its AirFit and AirTouch masks and certain medical devices. Then the company in December announced a voluntary global field action to update its guides.  “ResMed is recalling these masks to update the labels, add...

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material.  “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine...

AMSTERDAM – Philips has established a “recovery trajectory” for its sleep and respiratory care business, but discussions with the U.S. Department of Justice on a proposed consent decree to resolve identified issues could impact the company’s plans. The company’s trajectory includes an estimated EUR 600 million in sales of Respironics sleep systems by 2025, up from an expected EUR 200 million in 2022 and more in line with the EUR 700 million in 2019, pre-recall.  “This...