Z-1030-2026Class II

Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU

Name: Z-1030-2026 Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU
Creator: Abiomed, Inc.
Published: 2025-12-04
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2025-12-04 / Open, Classified / root cause: packaging

FDA source

Abiomed, Inc. began a recall of Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU on 2025-12-04. FDA classified it as Class II and gives the reason as "Device packaged in incorrect outer box carton". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1030-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-04
Posted: 2026-01-08
Recalling firm: Abiomed, Inc.
Product: Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: Device packaged in incorrect outer box carton.
Root cause tag: packaging
FDA 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 in commerce: 6 units
Distribution: International distribution to the country of Australia and Taiwan.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1030-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-08

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)