FDA Device recall Z-1173-2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite by Impulse Dynamics Usa, citing 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 befo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1173-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-05 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Impulse Dynamics Usa |
| Distribution | US |
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
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.
Identifiers
| code_info | OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. Th…OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2024%22
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