Abiomed REF: 0052-3025 recall (Oscor Inc.)
Medical deviceClass IOngoing
Summary: Oscor Inc. is recalling Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.. Reason: 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.
What is being recalled
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Why
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.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Distribution in the US state of MA
How to tell if yours is affected
All Lots within Expiry/GTIN:00885672009793, 00813502010664
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2678-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | June 10, 2026 |
| Reported | July 22, 2026 |
| Company | Oscor Inc. |
| Company location | Palm Harbor, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 355 units |
More recalls from Oscor Inc. · all medical device recalls · recalls from June 2026