Medical Device Recall: OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
IMPULSE DYNAMICS (USA) INC · January 5, 2024
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.
Distribution
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
States Affected
NATIONWIDE
Quantity Affected
1,469 total units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1173-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.