Z-2679-2026 Class I Ongoing
FDA device recall Z-2679-2026 was initiated by Oscor Inc. on June 10, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 1332 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1332 units
Product Description
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. 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.
Distribution Pattern
Distribution in the US state of MA
Code Information
All Lots within Expiry/GTIN:00885672009786/00813502010558