Oscor recalls
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Oscor and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-22FDA-DeviceClass IAbiomed 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.
- 2026-07-22FDA-DeviceClass IAbiomed Impella introducer sheaths recalled for leakage risk
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.
- 2026-07-22FDA-DeviceClass IAbiomed Impella Introducer Kit recalled for leaking risk
Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.
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