FDA Device recall Z-2680-2026
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
- FDA Device
- Class I
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class I recall of Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces… by Oscor, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2680-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-10 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Oscor |
| Distribution | MA |
Product
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. 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.
Identifiers
| code_info | All Lots within Expiry/GTIN:00885672009755/00813502011609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2680-2026%22
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