FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Recall number
- Z-1030-2026
- Recalling firm
- Abiomed, Inc.
- Product
- Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Status
- Open, Classified
- Initiated
- 2025-12-04
- Posted
- 2026-01-08
- Terminated
- not on file
- Reason
- Device packaged in incorrect outer box carton.
- Root cause
- Under Investigation by firm
- Action
- The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.
- Quantity
- 6 units
- Distribution
- International distribution to the country of Australia and Taiwan.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- not on file
- PMA numbers
- ["P140003"]
- Product code
- OZD
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28