Vercise Genus Deep Brain Stimulation Device May Reset During Charging
Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The risk involves transient loss of stimulation and temporary symptom worsening that could prompt unnecessary surgical intervention, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling its Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) devices, including R16 and R32 IPG kits (reference numbers M365DB12160 and M365DB12320). These are implanted neurostimulation devices.
The issue: During routine system checks that occur while the device is charging, the IPG may unexpectedly reset. This reset causes a temporary loss of stimulation. Patients may experience undesired sensations and transient worsening of their symptoms, potentially leading some to request surgical intervention for device replacement or revision.
The affected devices were distributed worldwide. Patients using this device should contact their healthcare provider to discuss any concerns or if they experience unusual sensations or symptom changes during device charging.
The recalled product
- Product
- Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Affected units
- 14,977
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- M365DB12320/8714729985051/100104 - 753200/09-OCT-2020 through 21-MAR-2026
Distribution
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