Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Potential for the balloon in the device to not meet burst specifications.
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation d…
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.