FDA Device recall Z-2128-2023
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- FDA Device
- Class II
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 by Abiomed, citing there was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contam….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2128-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-26 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abiomed |
| Distribution | US |
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Reason
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Identifiers
| code_info | UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2128-2023%22
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