Vercise GenusRecalls & reported problems across all models

We found 5 models of Vercise Genus by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 891 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2021 and Sep 30, 2026 — classified as 31 deaths, 703 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (222 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vercise Genus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 8, 2025Open, Classified

   Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

   Z-2558-2025 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

2. Apr 18, 2024Open, Classified

   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.

   Z-1890-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported Vercise Genus problems

Vercise Genus models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vercise Genus™ DB-1216

  Stimulator, electrical, implanted, for essential tremor
  2 recalls23 deaths584 reports
• Vercise Genus™ DB-1416

  Stimulator, electrical, implanted, for parkinsonian tremor
  6 deaths240 reports
• Vercise Genus™ DB-1232

  Stimulator, electrical, implanted, for parkinsonian symptoms
  2 recalls2 deaths48 reports
• Vercise Genus™ DB-1408

  Stimulator, electrical, implanted, for essential tremor
  12 reports
• Vercise Genus™ DB-1432

  Stimulator, electrical, implanted, for parkinsonian symptoms
  7 reports

Recent Vercise Genus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Unexpected Therapeutic Results; Battery Problem

  Patient problems: Pain

  MAUDE report 50953251 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient that is implanted with the Deep Brain Stimulation (DBS) system, developed a bacterial infection at the Implantable Pulse Generator (IPG) site, with multiple symptoms including redness and inflamed skin. The patient underwent an IPG explant procedure, was prescribed antibiotics and is doing well post operatively. Cultures were taken; however, the results were not provided. It is unknown if the infection is device or procedure related. The IPG will not be returned for analysis as it was disposed of per the hospital policy.

  Patient problems: Bacterial Infection; Erythema; Swelling/ Edema

  MAUDE report 50942455 ↗
• InjurySep 29, 2026Charging Problem

  Patient problems: Implant Pain

  MAUDE report 50937754 ↗
• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation; Intermittent Energy Output

  It was reported that the Deep brain stimulation (DBS) patient experienced episodes of intermittent stimulation caused by the Implantable pulse generator (IPG), this was noticed when the patient was lying in bed. The patient indicated that this episode recurred on three more different times, and stimulation resumed immediately. The patient reported a sensation consistent with an increase in stimulation, resulting in a tingling sensation, unsteady walking and a vibrating sensation in the left side; however, at a later date the patient perceived the vibrating sensation on both sides. This situation caused discomfort and muscle/nerve tension, as the patient felt the muscle lock up for a couple of seconds and then release, causing pain in the chest area when it happened. The vibrating sensation evolved into a zapped sensation with a recurrence every 10 to 15 minutes. The patient reports feeling mentally tired as a consequence of this situation. The patient will undergo a revision procedure at a later stage.

  Patient problems: Balance Problems; Chest Pain; Fatigue; Inappropriate Device Stimulation of Tissue; Insufficient Information; Paresthesia

  MAUDE report 50920291 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the deep brain stimulation (DBS) patient passed away. No further information was able to be obtained regarding the patients death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876476 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Convulsion/Seizure; Hematoma

  MAUDE report 50876109 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient underwent a system explant procedure due to an infection localized subcutaneously in the neck area that spread to the lead. The patient experienced neck pain. Cultures were taken, indicating the presence of Staphylococcus sp. Per the physician, the infection was not device or procedure related. The devices were retained by the hospital and will not be returned for analysis. The patient was placed on antibiotics therapy, immediately after the explant procedure took place. Postoperatively, the patient was recovering well.

  Patient problems: Bacterial Infection; Neck Pain

  MAUDE report 50869031 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Wireless Communication Problem

  It was reported that the patient that is implanted with the Deep Brain Stimulation (DBS) system experienced difficulty charging of the Implantable Pulse Generator (IPG) causing a loss of stimulation, the return of their pre-existing Parkinson's disease symptoms of tremor, rigidity and bradykinesia, and the remote control would not connect to the IPG. The patient was provided with charging education and was able to charge the IPG, got it out of hibernation and was able to reconnect the remote control. The patient stated that they fell a few months ago onto the IPG pocket site, after which the physician examined the IPG pocket site, imaging was performed and no irregularities were identified. The patient underwent an IPG replacement procedure, therapy has been restored and is doing well post operatively.

  Patient problems: Bradycardia; Fall; Shaking/Tremors; Unspecified Musculoskeletal problem

  MAUDE report 50862389 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Use of Device Problem; Device Displays Incorrect Message; Wireless Communication Problem

  It was reported that during a non-Boston Scientific related procedure to implant a pacemaker the deep brain stimulation (DBS) implantable pulse generator (IPG) was damaged. It was indicated that the stimulation was not properly turned off before the procedure as they thought it had been. After the procedure was completed the IPG was unable to enter into pairing mode in order to turn the stimulation back on resulting in a return of tremors in the upper extremities. Attempts were made to establish a connection between the remote control (RC) and IPG but continued to receive communication error messages. Attempts were made to evaluate the IPG but were unsuccessful as communication could not be established between the clinician programmer (CP) and IPG. It was indicated that before the procedure began the sales representative misread the type of IPG model the patient was implanted with and suggested using a magnet to turn the device stimulation off to expedite the process and not cause any delays with the procedure. Upon doing so in pre-op the patient was asked if he felt the device stimulation turn off and he said yes and also exhibited tremor symptoms which led to the belief that the

  Patient problems: Shaking/Tremors

  MAUDE report 50857148 ↗
• InjurySep 21, 2026Battery Problem

  It was reported that the patient underwent a deep brain stimulation (DBS) implantable pulse generator (IPG) replacement due to end of life (EOL). No patient complications were reported. The patient's postoperative status was reported as expected with no complications. The explanted device was retained by the hospital and was not returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842550 ↗
• DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a deep brain stimulation (DBS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831583 ↗
• DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient passed away from natural causes. The cause of death is not believed to be device related; however, it remains unconfirmed. The patient had Parkinson's disease, which was considered a comorbidity that could have contributed to the patient's death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820364 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Deep Brain Stimulation (DBS) device was replaced due to an unknown reason. The location of the replaced device is unknown. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790278 ↗
• InjurySep 14, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765205 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50765077 ↗

Other Boston Scientific Neuromodulation Corporation products

• Precision Spectra3 models · 11,348 reports
• Spectra WaveWriter4 models · 7,251 reports
• Precision17 models · 6,725 reports
• WaveWriter Alpha3 models · 4,356 reports · 1 recall
• Precision Montage MRI2 models · 4,332 reports
• Linear ST5 models · 4,068 reports
• Infinion CX2 models · 2,139 reports · 1 recall
• Superion5 models · 1,488 reports · 2 recalls