Reported Feb 28, 2024 · Ongoing
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Impulse Dynamics (usa) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IMPULSE DYNAMICS (USA) INC · 50 Lake Center Executive Pky /#100 · Marlton, NJ · 08053
Is this the product you have?
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Lot codes and dates
- OPTIMIZER Smart Mini UDI-DI00810003380098
- OPTIMIZER Lite UDI-DI00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1
- Amount recalled
- 1,469 total units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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