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.
Other recalls by Oscor
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor - Destino Twist 14F (also branded as Guidestar 14F)
FDA Device · Class II · 2022-02-23 · Oscor - AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
FDA Device · Class II · 2021-04-07 · Oscor - TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart
FDA Device · Class I · 2018-11-14 · Oscor
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2680-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.