FDA Medical devices recall ·
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2678-2026
- Date
- (initiated June 10, 2026)
- Company / brand
- Oscor Inc.
4875 Palm Harbor Blvd, Palm Harbor, FL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 355 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots within Expiry/GTIN:00885672009793, 00813502010664
Distribution
Distribution in the US state of MA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2678-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.