OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Reported: February 28, 2024 Initiated: January 5, 2024 #Z-1173-2024
Product Description
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.
Details
- Recalling Firm
- IMPULSE DYNAMICS (USA) INC
- Units Affected
- 1,469 total units
- Distribution
- Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
- Location
- Marlton, NJ
Frequently Asked Questions
What product was recalled? ▼
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite. Recalled by IMPULSE DYNAMICS (USA) INC. Units affected: 1,469 total units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1173-2024.
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