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

Recall Insight

This FDA Devices action (record #Z-1173-2024) was formally reported on February 28, 2024, with the manufacturer initiating the action on January 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Impulse Dynamics (USA) INC is listed as the recalling firm, operating out of Marlton, NJ. Federal records indicate 1,469 total units units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.