Reported Jun 5, 2024 · Ongoing
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG…
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
- Vercise Genus Deep Brain Stimulation (DBS)
- Implantable Pulse Generator IPGR16 IPG KIT
- REF
M365DB12160and R32 IPG KIT
- REFM365DB12320
- Lot codes and dates
2 of 2 products · 2 lot codes
Recalled lot codes, grouped by product number Number Range Expiration Date Range Lot codes and dates M365DB121608714729985044100209 - 753347/09-OCT-2020 through 26-MAR-2026
M365DB123208714729985051100104 - 753200/09-OCT-2020 through 21-MAR-2026
- Amount recalled
- 14,977
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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