FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Impella introducer sheaths recalled for potential leakage
What this means
Oscor Inc. has recalled certain Abiomed Impella Hemostatic Peel Away Introducer Kits (models 14Fr and 23Fr) due to manufacturing defects. The introducer sheaths may leak from the sidearm, under the sheath cap, or along hub score lines during use.
- If you have one of the affected introducer kits, contact Oscor Inc. or your healthcare provider immediately.
- Do not use the affected sheaths until you have received further guidance.
- Check the product lot number against the recall notice to confirm if your unit is affected.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution in the US state of MA
Affected count
1332 units
Manufactured in
4875 Palm Harbor Blvd, Palm Harbor, FL, United States
Products
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2679-2026More Oscor recalls
- FDA-Device2026-07-22Abiomed Impella Introducer Kit recalled for potential leaking in sheaths
- FDA-Device2026-07-22Abiomed Impella Introducer Kit recalled for potential leaking sheaths
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