Abiomed 14Fr Low Profile Introducer Set — Class II medical device recall Z-2128-2023
Ongoing recall by Abiomed, Inc., reported 2023-07-19, distributed nationwide. There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms ar
| Recall number | Z-2128-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-05-26 |
| Classified | 2023-07-11 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 37 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813502013252 |
| Lot numbers | 1725590, 1727033 |
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2128-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.