Drug recall
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
FDA recall event 94798 · Class II · Abbott Medical
Key facts
| Event ID | 94798 |
|---|---|
| Recall numbers | Z-2358-2024, Z-2359-2024, Z-2360-2024, Z-2361-2024, Z-2362-2024, Z-2363-2024, Z-2364-2024, Z-2365-2024, Z-2366-2024, Z-2367-2024, Z-2368-2024, Z-2369-2024 |
| Recalling firm | Abbott Medical |
| Product type | Devices |
| Products | Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only, Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only, Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only, Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only, Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only and 7 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. |
| Initiation date | May 16, 2024 |
| Report date | Jul 24, 2024 |
| City | Plano |
| State | TX |
| Country | United States |
| FEI number | 1627487 |
At a glance
- 10–99 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: