MEDICAL DEVICE RECALLCRITICAL

Oscor Impella Introducer Kit

Oscor recalls Abiomed Impella Introducer Kit (14F) due to sheath leakage risk.

What to do

Stop using the affected introducer kit immediately. Contact Oscor Inc. for instructions on returning the product and obtaining a replacement. If you have used this device on a patient, monitor for any signs of leakage or complications and report any adverse events to the FDA.

Recalled

2026-06-10

Listed

2026-07-10

Updated

2026-09-03

Recall No.

Z-2678-2026

Agency

FDA

Firm

Oscor Inc.

Recall ID

99102

Status

ONGOING

Why it was recalled

Oscor Inc. is recalling the Abiomed Introducer Kit for the Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm, due to a manufacturing issue that may cause the introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines. Leakage could compromise device performance and patient safety.

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	Lot code	Recall #	UDI-DI
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.	All Lots within Expiry/GTIN:00885672009793, 00813502010664	Z-2678-2026	00885672009793, 00813502010664
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.	All Lots within Expiry/GTIN:00885672009786/00813502010558	Z-2679-2026	00885672009786, 00813502010558
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.	All Lots within Expiry/GTIN:00885672009755/00813502011609	Z-2680-2026	00885672009755, 00813502011609

Where it was sold

Distributed in Massachusetts.

Timeline

2026-06-10Firm initiated recall
2026-07-10Publicly announced
2026-07-13Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification