The Recall Desk
SevereFDA (Devices)·Z-2599-2026·Announced 2026-07-01

Abiomed Impella CP Introducer Kit recalled for thrombus formation risk

Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. Per the rubric, FDA Class I recalls must score at least 4 (Severe), and are typically scored 4 or higher given the agency's classification of imminent risk to health.

Plain-English summary

Abiomed, Inc. is recalling the Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP (Impella Set Product Code: 1000434; Introducer Product Code: 1000434; Batch Number: 2038639) due to potential for thrombus (blood clot) formation during prolonged use of the introducer.

A total of 3 units have been distributed. Distribution was worldwide, with U.S. distribution in Florida, Illinois, Minnesota, New Jersey, New York, and Virginia, as well as in Japan.

Patients and healthcare providers who have received this product should contact Abiomed, Inc. for further instructions regarding the recall.

The recalled product

Product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Support / Introducer Kit
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Impella Set Product Code: 1000434
  • GTIN: 00813502012996
  • Serial Numbers: N/A. Introducer Product Code: 1000434
  • Batch Number: 2038639.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Abiomed, Inc.

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Same hazard · thrombus

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