FDA-Device2024-02-28Class II
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
IMPULSE DYNAMICS (USA) INC
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.
Sold states
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Affected count
1,469 total units
Manufactured in
50 Lake Center Executive Pky /#100, N/A, Marlton, NJ, United States
Products
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2024Don't want to check this manually?
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