Impella 5.5 with SmartAssist¿ S2 recall (Abiomed, Inc.)
Medical deviceClass IIOngoing
Summary: Abiomed, Inc. is recalling Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.. Reason: Device packaged in incorrect outer box carton.
What is being recalled
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Why
Device packaged in incorrect outer box carton.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the country of Australia and Taiwan.
How to tell if yours is affected
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1030-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 4, 2025 |
| Reported | January 14, 2026 |
| Company | Abiomed, Inc. |
| Company location | Danvers, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6 units |
More recalls from Abiomed, Inc. · all medical device recalls · recalls from December 2025