JNJ · News · 20260828N

Impella Product Safety Recall

JOHNSON & JOHNSON · 2026-08-28 · Importance 47 · Surprise 60

J&J’s Abiomed business recalled Automated Impella Controllers after component failures were linked to three patient deaths and 37 serious injuries. The purge flag component failure caused purge cassette recognition problems in 0.2% of cases. Hospitals may continue using existing inventory for continuity of care, while Abiomed plans component replacements through annual maintenance or service outreach and recommends using a backup controller if an alarm occurs.

Key facts

• The company recommends reinserting the purge disc or switching to a backup AIC if an alarm occurs. source
• Johnson & Johnson plans to replace the faulty components through annual maintenance or service outreach. source
• The issue, identified in 0.2% of cases, involves purge cassette recognition problems due to failures of the purge flag component. source