Class II — IMPULSE DYNAMICS (USA) INC
| Recalling firm | Impulse Dynamics USA Inc |
|---|---|
| Registered facility | Impulse Dynamics USA Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 the device. |
| Product | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite |
| Quantity | 1,469 total units |
| Distribution | Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden. |
| Initiated | 2024-01-05 |
| Classified | 2024-02-22 |
| Recall number | Z-1173-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IMPULSE DYNAMICS (USA) INC (Z-1173-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93791/
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