FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter mitral valve replacement.
The alert cites three reports of balloons rupturing during inflation, which could cause embolism or make the device unretrievable, possibly requiring surgery.
Edwards has sent a letter to customers advising removal of the affected Commander M delivery systems with lot numbers 67718561, 67804014, 67887043, and 67887044 from use or sale, and to return them to the company.
Units with other lot numbers are not affected. Hospitals are instructed to inform clinical staff, search inventory, and coordinate returns while monitoring the FDA webpage for updates.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences”
read at fda medwatch ↗
comments(0)
5-min edit window · permanent after that