FDA recall Z-1173-2024

Product

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-01-05

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2024