Reported Jan 14, 2026 · Ongoing
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Impella 5.5 with SmartAssist¿ S2Impella 5.5 with SmartAssist S2 SetAU
- Lot codes and dates
- Catalog Number1000482
- Australian Configuration Code1000770
- GTIN
00813502012828Serial No. 621454 & 621455Exp. Date 6/30/27. *** UPDATE 05/02/2026***
- Serial numbers added
621448621449621450and 621451
- Amount recalled
- 6 units
Why it was recalled
Device packaged in incorrect outer box carton.
This product could cause temporary or reversible health problems — stop using it.
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