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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
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 23, 2026 at 11:04 PM UTC.
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