Johnson & Johnson Recalls Impella Controllers Following Purge Pressure Faults

Johnson & Johnson’s Abiomed unit has issued a recall of certain Automated Impella Controllers after identifying a purge pressure issue linked to five serious injuries, though no deaths have been reported. The devices, which serve as the main interface for controlling Impella heart pumps, enable physicians to maintain circulatory support during high-risk procedures or cardiac shock.

The fault stems from purge retainer failures, caused by force applied when inserting or removing purge discs, potentially leading to pump stoppages and interruptions in hemodynamic support. J&J is implementing a design change by adding a screw to the purge retainer, correcting the problem during servicing. The modification has already been completed in 91% of affected devices globally.

This recall marks the third recent safety action involving Impella devices, following previous alerts linked to three and one deaths, highlighting ongoing concerns over device reliability and patient safety.

27-09-2025