Oscor Abiomed Impella Introducer Kits
The introducer kit for the Impella system may leak from the sidearm, under the sheath cap, and along hub score lines.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Oscor Inc. of Palm Harbor, Florida, recalled certain Abiomed Introducer Kits for the Impella Hemostatic Peel Away Introducer System with Infusion Sideport due to manufacturing issues that may cause 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. The recall began June 10, 2026, and was added to the FDA's Enforcement Report on July 10, 2026, with Massachusetts named as a affected state.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
3 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- UDI-DI
- 00885672009793
- 00813502010664
- Lot
- All Lots within Expiry/GTIN:00885672009793, 00813502010664
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
- UDI-DI
- 00885672009786
- 00813502010558
- Lot
- All Lots within Expiry/GTIN:00885672009786/00813502010558
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- UDI-DI
- 00885672009755
- 00813502011609
- Lot
- All Lots within Expiry/GTIN:00885672009755/00813502011609
Details
- Company began the recall
- Sold in
- Event ID
- 99102
- Recall numbers
- Z-2678-2026 to Z-2680-2026
- Company
- Oscor Inc.Palm Harbor, Florida
- Hazard
- Manufacturing deviation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
