medical Class II Updated 2024-02-28

IMPULSE DYNAMICS (USA) INC recalls OPTIMIZER model CCM X11 implantable pulse generator (IPG) de

Recalled Product

OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

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