JNJ · News · 20260828N
Impella Controller Safety Recall
JOHNSON & JOHNSON · 2026-08-28 · Importance 47 · Surprise 60 · In source text
Johnson & Johnson’s Abiomed business initiated a recall of Automated Impella Controllers after component failures were linked to three patient deaths and 37 serious injuries. The purge flag failure caused purge cassette-recognition problems and occurred in approximately 0.2% of cases. Hospitals were advised to remove affected controllers from use while maintaining patient-care continuity with existing inventory, and Abiomed plans component replacements through annual maintenance or service outreach.
Key facts
- Johnson & Johnson's Abiomed business has initiated a recall for automated Impella heart pump controllers due to component failures that have been linked to three deaths and 37 serious injuries. source
- Hospitals are advised to remove the affected controllers from use but can continue using existing inventory while awaiting service to ensure continuity of patient care. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| liability | negative | committed | — | Johnson & Johnson's Abiomed business has initiated a recall for automated Impella heart pump controllers due to component failures that… |
| liability | negative | contingent | — | Johnson & Johnson's Abiomed business has initiated a recall for automated Impella heart pump controllers due to component failures that… |