Recall Z-2678-2026— Oscor Inc.
Class I · Ongoing
Class I FDA medical device recall by Oscor Inc., initiated 2026-06-10. 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
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.