Boston Scientific recalls Vercise Genus Deep Brain Stimulation implantable pulse generators with specific model numbers due to potential device reset during charging, which may cause temporary loss of stimulation and worsened symptoms.
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.
Boston Scientific is recalling Vercise Genus Deep Brain Stimulation implantable pulse generators (IPGs) with specific model numbers. The recall is due to a potential device reset during charging that could cause temporary loss of stimulation, leading to worsened movement disorder symptoms or patient requests for surgical revision.
The IPG may reset during routine charging, causing temporary loss of stimulation. This can lead to undesired sensations and temporary worsening of movement disorder symptoms, potentially prompting patients to request surgical intervention for replacement.
Patients with Vercise Genus Deep Brain Stimulation implants using the recalled IPG models are affected. Those with the specific model numbers and serial ranges are most at risk of experiencing temporary stimulation loss or worsened symptoms.
Check for the model numbers R16 IPG KIT (REF: M365DB12160) or R32 IPG KIT (REF: M365DB12320). The serial numbers range from 8714729985044 to 8714729985051 with expiration dates between October 2020 and March 2026.
Identify if your IPG is one of the recalled models (R16 or R32) with the specified serial number ranges.
Reach out to Boston Scientific for guidance on next steps if you have a recalled device.
The recalled devices are R16 IPG KIT (REF: M365DB12160) and R32 IPG KIT (REF: M365DB12320) with serial numbers ranging from 8714729985044 to 8714729985051.
Device reset may cause temporary loss of stimulation, leading to undesired sensations and temporary worsening of movement disorder symptoms.
No, but you should check if your device is recalled and contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1890-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1890-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
