Marlton, NJ, United States
IMPULSE DYNAMICS (USA) INC recalls
1 recall recorded since 2018, most recently on 5 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 January 2024
- 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.
- Distribution
- Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1173-2024
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.