FDAFDA recall Z-2679-2026 · Jul 22, 2026
Oscor Inc.: Abiomed REF: 0052-3021 recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- All Lots within Expiry/GTIN:00885672009786/00813502010558
- Quantity
- 1332 units
- Distribution
- Distribution in the US state of MA
- Recalling firm
- Oscor Inc., Palm Harbor, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-10
Source: openFDA enforcement record Z-2679-2026 · search recall number Z-2679-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.