FDA recall, , Moderate risk
Abiomed Impella 5.5 with SmartAssist S2
The Impella 5.5 with SmartAssist S2 Set is packaged in an incorrect outer box carton.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, began a recall of the Impella 5.5 with SmartAssist S2 Set on December 4, 2025, because the device was packaged in an incorrect outer box carton. The recall involves 6 units and was added to the FDA's Enforcement Report on January 8, 2026, with international distribution to Australia and Taiwan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- UDI-DI
- 00813502012828
Recall details
- Company began the recall
- Sold in
International distribution to the country of Australia and Taiwan.
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98086
- Recall number
- Z-1030-2026
- Quantity recalled
- 6 units
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
