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IMPULSE DYNAMICS (USA) INC recalls OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Recalled February 28, 2024 · FDA recall Z-1173-2024 · IMPULSE DYNAMICS (USA)
Hazard
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. · FDA Class II
Units
1,469 total units
Sold at
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Description
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.
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Manufacturer(s)
IMPULSE DYNAMICS (USA) INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →