OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
This recall is currently active, issued February 22, 2024. It was issued by Impulse Dynamics (Usa) Inc.
- Company
- Impulse Dynamics (Usa) Inc
- Recall Initiated
- January 5, 2024
- Posted
- February 22, 2024
- Recall Number
- Z-1173-2024
- Quantity
- 1,469 total units
- Firm Location
- Marlton, NJ
- Official Source
- View on FDA website ↗
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
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
On January 2, 2024, the firm sent letters to field representatives to be given to affected physicians. Summary of the safety communication can be found online: https://impulse-dynamics.com/safety-information/ The firm recommends all patients with implant card showing model CCM X11, who have experienced the "A9" charge error, charge their implanted device to no more than 75% of full capacity to circumvent the issue. See link above for instructions. If a patient encounters an A9 error code, CCM therapy has been suspended and must be manually reset. Patients should schedule time with an Impulse Dynamics representative or their physician to manually reset their device. The firm is working on a software update to address this issue. Patients and clinicians may determine if a specific device is affected by providing the serial number of any specific device to the Technical Support Hotline at 866-312-5370.