FDAFDA · Food and drugs·Recall number Z-1173-2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Published February 28, 2024 · Recall initiated: January 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- IMPULSE DYNAMICS (USA) INC
- Distributor
- Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
- Lot
- OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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