Heart pump sets recalled after being packaged in the wrong outer carton
Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an incorrect outer carton with no stated consequence or reported harm.
Plain-English summary
The Impella 5.5 with SmartAssist S2 and the Impella 5.5 with SmartAssist S2 Set, AU, are being recalled by Abiomed, Inc.
The reason given in the enforcement record is that the device was packaged in an incorrect outer box carton.
The record lists 6 units, catalog number 1000482 with Australian configuration code 1000770 and GTIN 00813502012828, including serial number 621454. Distribution was international, to Australia and Taiwan. The FDA has classified the action as Class II.
The record describes a packaging error and states no consequence or reported injuries. Facilities should follow Abiomed's instructions.
The recalled product
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Heart pump
- Affected units
- 6
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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