Abiomed Impella Introducer Sheath
Oscor recalls Abiomed Impella introducer sheaths (14Fr, 23Fr) due to leakage risk from sidearm and hub.
Check the affected introducer kits (REF 0052-3006 for 23Fr, REF 0052-3025 for 14Fr) and discontinue use immediately. Return unused products to Oscor Inc. for replacement or credit.
Why it was recalled
Oscor Inc. is recalling Abiomed Impella Hemostatic Peel Away Introducer Systems (14Fr and 23Fr) due to a manufacturing defect that may cause the introducer sheath to leak from the sidearm, under the sheath cap, or along the hub score lines. Leakage could lead to blood loss, hemodynamic instability, or delayed treatment.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. | 00885672009793, 00813502010664 | Z-2678-2026 |
| Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories. | 00885672009786, 00813502010558 | Z-2679-2026 |
| Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. | 00885672009755, 00813502011609 | Z-2680-2026 |
Where it was sold
Distributed in Massachusetts.
Official source
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification