Official recall record
Vercise Genus ™ R16 and R32 Implantable Pulse Generator (IPG) Kits
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-08-12
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
Manufacturer is initiating an advisory to remind customers to follow steps outlined in the labeling/instructions for use to implant Vercise Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs) within a subcutaneous pocket. Device header feedthrough (FT) wire break(s) have occurred in rechargeable Vercise Genus ™ DBS IPGs that were implanted submuscular in the pectoral location. Manufacturer has not received reports of FT wire breaks with Vercise Genus ™ DBS IPGs implanted in a subcutaneous pocket. Complete or partial breaks of device header FT wire(s) will prevent successful delivery of stimulation therapy, thus requiring removal/replacement of the device. Clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or bluetooth connectivity challenges may be potential signals associated with FT wire break(s). Recall start date: August 8, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.