Drug recall
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA recall event 92521 · Class II · Abiomed, Inc.
Key facts
| Event ID | 92521 |
|---|---|
| Recall numbers | Z-2128-2023 |
| Recalling firm | Abiomed, Inc. |
| Product type | Devices |
| Products | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 26, 2023 |
| Report date | Jul 19, 2023 |
| City | Danvers |
| State | MA |
| Country | United States |
| FEI number | 1220648 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: