IMPULSE DYNAMICS (USA) INC: Medical Device Recall in 2024 - (Recall #: Z-1173-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 5, 2024

Date Posted: February 28, 2024

Recall Number: Z-1173-2024

Event ID: 93791

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.

Status: Ongoing

Product Quantity: 1,469 total units

Code Information:

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.

Distribution Pattern:

Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated