Oscor Inc. recalls Abiomed REF: 0052-3025
- Recalling company
- Oscor Inc.
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jun 10, 2026
- Reported
- Jul 22, 2026
- Distribution
- Distribution in the US state of MA
- Status
- Ongoing
- Quantity
- 355 units
- Lot / codes
- All Lots within Expiry/GTIN:00885672009793, 00813502010664
- Company location
- Palm Harbor, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2678-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2678-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.