FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Impella Introducer Kit recalled for potential leaking in sheaths
OTHERMA
Abiomed Impella Introducer Kit recalled for leaking risk
Abiomed's Impella Hemostatic Peel Away Introducer Kit (models 14Fr and 23Fr) may leak from the sidearm, under the sheath cap, or along hub seams due to manufacturing defects. The affected products were distributed in Massachusetts. No injuries have been reported.
- Contact Abiomed immediately if you have received this product
- Do not use affected units until you receive further instructions
- Check the lot number and expiration date against the FDA notice
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.
Sold states
Distribution in the US state of MA
Affected count
32,934 units
Manufactured in
4875 Palm Harbor Blvd, Palm Harbor, FL, United States
Products
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2680-2026More Oscor Inc. recalls
- FDA-Device2026-07-22Abiomed Impella Introducer Kit recalled for potential leaking sheaths
- FDA-Device2026-07-22Abiomed Impella introducer sheaths recalled for potential leakage
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