The US FDA gave its highest risk designation to Cook’s recall of its Fixed Core Wire Guide.
The recall of a guide wire made by Cook Medical LLC has been designated high-risk class I by the US Food and Drug Administration.
The problematic Cook Medical Fixed Core Wire Guide, manufactured on 24 August and distributed on 9 September, is used to...
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Tandem Diabetes Care initiated a recall last month of several t:slim X2 insulin pumps due to a “malfunction 16” error that can cause the pumps to shut down. The problem is triggered by wiring within the device speaker.
A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
Tandem Diabetes Care initiated a recall last month of several t:slim X2 insulin pumps due to a “malfunction 16” error that can cause the pumps to shut down. The problem is triggered by wiring within the device speaker.
Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.
The US FDA received over two dozen comments from stakeholders on the next round of the medical device user fee amendments, which will establish funding for fiscal years 2028 through 2032.
