FDAClass I · Medical device · Recalled July 1, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Hazard: Potential for thrombus formation during prolonged use of the introducer.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2599-2026
Brand: Abiomed
Classification: Class I
Units affected: 3 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Affected products

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP

Companies & origin

Recalling firm location: Danvers, MA, United States
Firm address: 22 Cherry Hill Dr, N/A, 01923-2575

Identifying details (verbatim from the notice)

Product codes / lots: Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Firm notified the public via: Letter
FDA event ID: 99002
Recall initiated: May 22, 2026
FDA classified: June 25, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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