Recall Z-2599-2026— Abiomed, Inc.

Name: FDA recall Z-2599-2026
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 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.. 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 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

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.