Impella Heart Pump recallZ-2599-2026 · Abiomed, Inc. · initiated May 22, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Potential for thrombus formation during prolonged use of the introducer.
FDA root cause category: Under Investigation by firm
What the company is doing
Abiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.
Recall details
- Recall number
- Z-2599-2026
- Status
- Open, Classified
- Initiated by the company
- May 22, 2026
- Posted by the FDA
- Jun 25, 2026
- Recalling firm
- Abiomed, Inc.
- Quantity
- 3 units
- Product code
- DYB
- FDA submissions
- K241708
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Product description
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Code information (models, lots, serial numbers)
Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Impella 1000434Abiomed, Inc. · Introducer, Catheter1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99002).
- Z-2600-2026 · Open, ClassifiedAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- Z-2601-2026 · Open, ClassifiedAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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