Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Pending LLM rewrite. Source: FDA_DEVICE Z-1030-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Device packaged in incorrect outer box carton.
The recalled product
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distribution scope not specified by the agency.
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