Z-1173-2024 Class II Ongoing
FDA device recall Z-1173-2024 was initiated by IMPULSE DYNAMICS (USA) INC on January 5, 2024 and is designated Class II. Reason for recall: 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 th… The recall status is ongoing. Affected quantity: 1,469 total units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- January 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,469 total units
Product Description
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Reason for Recall
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.
Distribution Pattern
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Code Information
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.