Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: Recalled by Boston Scientific Neuromodulation Corporation Due to Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Neuromodulation Corporation directly.
Affected Products
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Quantity: 14,977
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Neuromodulation Corporation
Boston Scientific Neuromodulation Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report