FDAJanuary 5, 2024device
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
impulse dynamics usaimpulseimpulse dynamics
UPCs
0081000338009800810003380142
Recall history
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