[pending] Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Pending LLM rewrite. Source: FDA_DEVICE Z-1030-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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