Recall Z-2678-2026— Oscor Inc.

Name: FDA recall Z-2678-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Class I · Ongoing

Class I FDA medical device recall by Oscor Inc., initiated 2026-06-10. It names one FDA 510(k) clearance: K122084. Product: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.. Reason: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region..

Recalling firm: Oscor Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-06-10
Firm location: Palm Harbor, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIESOscor, Inc.·cleared 2012-08-29

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 REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

Reason for recall

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

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