Recall Z-1173-2024— IMPULSE DYNAMICS (USA) INC
Class II · Ongoing
Class II FDA medical device recall by IMPULSE DYNAMICS (USA) INC, initiated 2024-01-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- IMPULSE DYNAMICS (USA) INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-05
- Firm location
- Marlton, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.