FDAClass I · Medical device · Recalled July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro 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-2602-2026
Brand: Abiomed
Classification: Class I
Units affected: 7 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Affected products

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro

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: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
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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