Impella 5.5 with SmartAssist¿ S2 recall
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Why was Impella 5.5 with SmartAssist¿ S2 recalled?
Device packaged in incorrect outer box carton.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Recalling firm
- Abiomed, Inc.
- Quantity
- 6 units
- Distribution
- International distribution to the country of Australia and Taiwan.
- Recall date
- January 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)