FDA Medical Device Recalls (openFDA)
IMPULSE DYNAMICS (USA) INC: OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Recall number
- Z-1173-2024
- Recalling firm
- IMPULSE DYNAMICS (USA) INC
- Product
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Status
- Open, Classified
- Initiated
- 2024-01-05
- Posted
- 2024-02-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 1,469 total units
- Distribution
- Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P180036S021","P180036S025","P180036S007"]
- Product code
- QFV
- Firm FEI
- 3017555074
- Firm city
- Marlton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28