Recall Z-2601-2026— Abiomed, Inc.

Name: FDA recall Z-2601-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Class I · Ongoing

Class I FDA medical device recall by Abiomed, Inc., initiated 2026-05-22. It names one FDA 510(k) clearance: K241708. Product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.. Reason: Potential for thrombus formation during prolonged use of the introducer..

Recalling firm: Abiomed, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-05-22
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K241708 — Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc.·cleared 2024-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Reason for recall

Potential for thrombus formation during prolonged use of the introducer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.