Z-1173-2024Class II

OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

Name: Z-1173-2024 OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Creator: Impulse Dynamics (USA) Inc
Published: 2024-01-05
License: https://open.fda.gov/license/

Impulse Dynamics USA Inc / initiated 2024-01-05 / Open, Classified / root cause: software

FDA source

IMPULSE DYNAMICS (USA) INC began a recall of OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite on 2024-01-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1173-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-05
Posted: 2024-02-22
Recalling firm: Impulse Dynamics USA Inc
Product: OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Product code: QFV Implantable Pulse Generator
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.
Root cause tag: software
FDA 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 in commerce: 1,469 total units
Distribution: Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1173-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1173-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22

Product code QFV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)