Recall Z-1890-2024— Boston Scientific Neuromodulation Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2024-04-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320. Reason: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-18
- Firm location
- Valencia, CA, United States
Product description
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Reason for recall
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
Data sourced from openFDA. This site is unofficial and independent of the FDA.