MEDICAL DEVICE RECALLCRITICAL

Abiomed Impella CP Introducer Kit

Abiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.

What to do

Stop using the affected introducer kit immediately and contact Abiomed for instructions on returning the product and obtaining a replacement.

Recalled

2026-05-22

Listed

2026-06-25

Updated

2026-09-03

Recall No.

Z-2601-2026

Agency

FDA

Firm

Abiomed, Inc.

Recall ID

99002

Status

ONGOING

Why it was recalled

Abiomed is recalling the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to a potential for thrombus formation during prolonged use of the introducer. The affected product is identified by Impella Set Product Code 1000434 and Introducer Product Code 1000434.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Product	Lot code	Recall #	UDI-DI
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.	2026724558, 2027818724, 1000834, 2026787668, 2027818660	Z-2601-2026	00813502013566, 2026724558, 2027818724, 00813502013948, 2026787668, 2027818660
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.	2038707, 2045782	Z-2600-2026	00813502013009
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.	2038639	Z-2599-2026	00813502012996
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.	2041530, 1000542	Z-2602-2026	813502013467

Where it was sold

Distributed nationwide.

Timeline

2026-05-22Firm initiated recall
2026-06-25Publicly announced
2026-06-26Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Other recent recalls from Abiomed, Inc.

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All recalls from Abiomed, Inc.

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification