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Impella Heart Pump recallZ-1030-2026 · Abiomed, Inc. · initiated Dec 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Device packaged in incorrect outer box carton.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1030-2026
Status
Open, Classified
Initiated by the company
Dec 4, 2025
Posted by the FDA
Jan 8, 2026
Recalling firm
Abiomed, Inc.
Quantity
6 units
Product code
OZD
FDA submissions
P140003
Distribution
International distribution to the country of Australia and Taiwan.

Product description

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

Code information (models, lots, serial numbers)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

11 devices cleared under P140003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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