OPTIMIZER model CCM X11 implantable pulse generator — Class II medical device recall Z-1173-2024
Ongoing recall by IMPULSE DYNAMICS (USA) INC, reported 2024-02-28, distributed nationwide. OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This ma
| Recall number | Z-1173-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMPULSE DYNAMICS (USA) INC, Marlton, NJ, United States |
| Recall initiated | 2024-01-05 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CZ, DE, ES, HR, IT, PL, RO, RU, SE |
| Quantity | 1,469 units |
| UPC / GTIN / UDI-DI | 00810003380098, 00810003380142 |
| Model numbers | X11 |
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
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 the device.
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-1173-2024. 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.