The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.
Two deaths have been linked to a recall of Medtronic PLC stents that was labeled high-risk class I by the US Food and Drug Administration on 20 September, the agency says.
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The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.
The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.
The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.
Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.
Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.
“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.
