Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Recalled by IMPULSE DYNAMICS (USA) INC Due to OPTIMIZER devices may cease to deliver CCM therapy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact IMPULSE DYNAMICS (USA) INC directly.
Affected Products
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Quantity: 1,469 total units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About IMPULSE DYNAMICS (USA) INC
IMPULSE DYNAMICS (USA) INC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report