Johnson & Johnson subsidiary Abiomed, Inc. is recalling the ABIOMED Impella CP heart pump set. The FDA designated this as a Class 1 recall, which is the most urgent classification for potential fatalities.
A manufacturing defect causes the device's introducer sheath to leak. This failure is not visually detectable by the user.
The recall affects 557 units distributed worldwide. Abiomed initiated the recall on June 11, 2026. The FDA posted the notice around July 10-11.
Abiomed issued an "URGENT MEDICAL DEVICE RECALL (CORRECTION)" notice to all affected consignees. The notice provides specific instructions for medical practitioners.