OPTIMIZER CCM X11 Pulse Generator (Impulse Dynamics) – Therapy Delivery Risk (2024)
Software errors in medical devices can potentially cause interruption of critical heart failure therapy.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Brand
IMPULSE DYNAMICS (USA) INC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
IMPULSE DYNAMICS (USA) INC is recalling OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite due to OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart fai. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026