Drug recall
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
FDA recall event 93791 · Class II · IMPULSE DYNAMICS (USA) INC
Key facts
| Event ID | 93791 |
|---|---|
| Recall numbers | Z-1173-2024 |
| Recalling firm | IMPULSE DYNAMICS (USA) INC |
| Product type | Devices |
| Products | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of… |
| Initiation date | Jan 5, 2024 |
| Report date | Feb 28, 2024 |
| City | Marlton |
| State | NJ |
| Country | United States |
| FEI number | 3017555074 |
At a glance
- 1–9 Products in this recall
- 1–9 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: