IMPULSE DYNAMICS (USA) INC recalls OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

Recall date

January 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1173-2024

FDA classification

Class II

Brand / firm

IMPULSE DYNAMICS (USA) INC

Sold / distributed

Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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