OPTIMIZER recallZ-1173-2024 · Impulse Dynamics (USA) Inc · initiated Jan 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Impulse Dynamics (USA) Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1173-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 5, 2024
- Posted by the FDA
- Feb 22, 2024
- Recalling firm
- Impulse Dynamics (USA) Inc
- Quantity
- 1,469 total units
- Product code
- QFV
- FDA submissions
- P180036S021, P180036S025, P180036S007
- Distribution
- Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Product description
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- OPTIMIZER Smart MiniImpulse Dynamics (usa) Inc. · Implantable Pulse Generator1 recall2 deaths125 reports
- OPTIMIZER LiteImpulse Dynamics (usa) Inc. · Implantable Pulse Generator1 recall5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page