Tag: Recall
Abbott recalls certain sensors
September 9, 2024HME News Staff
ABBOTT PARK, Ill. - Abbott has issued a recall for certain FreeStyle Libre 3 sensors due to a risk for inaccurate high glucose readings. On July 24, the company sent all affected customers an urgent medical device recall recommending they, among other things, immediately discontinue use and dispose of any affected sensors, and request a replacement for any affected seniors. Abbott initiated the recall after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose...
Tandem offers update on recall
August 21, 2024HME News Staff
SAN DIEGO – Tandem Diabetes Care on Aug. 9 emailed notices to customers impacted by a recall of its Apple OS t:connect mobile app. The recall, issued in March, relates to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery, causing the insulin pump to shut down sooner than expected. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Tandem strongly...
Inspire recalls implantable pulse generator
July 10, 2024HME News Staff
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...
FDA, Philips address potential vent malfunction
July 1, 2024HME News Staff
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...
FDA announces Ventec vent recall
March 11, 2024HME News Staff
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...
Philips sends more MDRs to FDA
February 5, 2024HME News Staff
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...
Providers feel squeezed in wake of Philips exit
February 2, 2024Theresa Flaherty, Managing Editor
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....
Philips agrees to terms of consent decree
January 29, 2024HME News Staff
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...
ResMed on mask recall, big tech and demand-gen
January 26, 2024Liz Beaulieu, Editor
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...
FDA classifies ResMed recall
January 15, 2024HME News Staff
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...