Vercise CartesiaRecalls & reported problems across all models

We found 2 models of Vercise Cartesia by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 813 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2018 and Sep 30, 2026 — classified as 19 deaths, 775 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (157 reports).

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

Most reported Vercise Cartesia problems

Vercise Cartesia models

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

• Vercise™ Cartesia™ DB-2202-45

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  18 deaths718 reports
• Vercise™ Cartesia™ DB-2202-30

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  1 death95 reports

Recent Vercise Cartesia adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; Speech Disorder

  MAUDE report 50953427 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  Patient problems: Shaking/Tremors

  MAUDE report 50941504 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Pain; Perforation; Purulent Discharge; Unspecified Infection

  MAUDE report 50926040 ↗
• InjurySep 18, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825418 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796865 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with a deep brain stimulation (DBS) system underwent an explant procedure for an unspecified reason. Postoperatively, patient is reported to be at baseline status. Explanted device is unable to return as was disposed of by facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791712 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 50680672 ↗
• InjuryAug 18, 2026Nonstandard Device

  It was reported that during an office follow up visit it was noted that the patient who is implanted with the Deep Brain Stimulation (DBS) leads developed a needle sized dehiscence on the left side but appeared well. While at home the patient experienced convulsions and was hospitalized, Computerized Tomography Scan (CT) imaging was performed, and a strange shape was seen in the results. The patient underwent a revision procedure.It was stated that nothing of note occurred during the procedure that may have contributed to the patient's condition, however, it was noted that the patient has thin skin. During the revision procedure the left lead and left burr hole cover were explanted, however it is unknown which of the two implanted leads or burr hole covers was explanted. Infection was confirmed on the left side, and the patient was prescribed antibiotics. The patient is doing well post operatively, and therapy has been restarted. The devices were retained by the facility.

  Patient problems: Convulsion/Seizure; Unspecified Infection; Wound Dehiscence

  MAUDE report 50291907 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep Brain Stimulation (DBS) patient underwent a lead and burr hole cover explant due to erosion. No additional adverse patient effects were reported. The location of the explanted devices is unknown.

  Patient problems: Erosion

  MAUDE report 50288797 ↗
• InjuryAug 12, 2026Migration

  It was reported that the patient underwent a revision procedure of the right sided lead of the Deep Brain Stimulation (DBS) system, in which the lead was repositioned, during the stage 2 implant due to the lead having migrated following the stage 1 implant which was confirmed with Computerized Tomography Scan (CT) imaging. It is unclear as to which of the two leads was repositioned. We completed a good faith effort to obtain additional information, unfortunately were unable to obtain more information. If additional details become available, a supplemental report will be submitted. No devices will be returned as they remain implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217998 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a scalp rash in the area of the Deep Brain Stimulation (DBS) implant. The patient did not seek medical treatment for several weeks and reportedly concealed the rash with a wig. Upon evaluation by the neurosurgery team, the patient was referred to a dermatologist for further assessment. Dermatologic treatment was initiated and the rash resolved; however, resolution of the rash revealed complete erosion of the overlying skin with full exposure of the burr hole cover. The patient was also reported to be on long-term steroid therapy, which was considered a potential contributing factor due to compromised skin thickness and elasticity. As part of the intervention, the lead and burr hole cover associated with the exposed hardware were explanted. The wound was cleaned, and a plastic surgery team performed closure of the surgical site. Postoperatively, the patient's status was not reported. The explanted devices will not be returned for analysis, as they were disposed of.

  Patient problems: Erosion; Rash

  MAUDE report 50136742 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy; Numbness; Speech Disorder

  MAUDE report 50124577 ↗
• InjuryJul 31, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate stimulation from the leads of the Deep Brain Stimulation (DBS) causing their preexisting symptoms to return. The patient underwent a procedure in which two leads and the burr hole cover were explanted. The patient is doing well post operatively.We completed a good faith effort to obtain additional information, if additional details become available, a supplemental report will be submitted.

  Patient problems: Insufficient Information; Shaking/Tremors

  MAUDE report 50107625 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent Deep Brain Stimulation (DBS) implantation and subsequently developed postoperative symptoms suggestive of cognitive dysfunction, as well as dizziness. A computed tomography (CT) scan revealed edema surrounding the implanted electrode. No additional neurological deficits were reported. As part of the intervention, steroid therapy was administered to treat the edema. While the relationship between the edema and the reported symptoms could not be definitively established, the patient's cognitive symptoms and dizziness resolved following treatment. The event did not result in an extension of the original hospital stay. The patient was subsequently discharged from the hospital without reported issues related to treatment.

  Patient problems: Cognitive Changes; Dizziness; Swelling/ Edema

  MAUDE report 50003184 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AT THE LEAD IMPLANT SITE. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO A NON-DBS SURGICAL PROCEDURE PERFORMED NEAR THE LEAD INCISION SITE, WHICH FAILED TO HEAL DESPITE ANTIBIOTIC TREATMENT. AS THE CONDITION DID NOT IMPROVE OVER SEVERAL MONTHS, THE PATIENT WAS ADMITTED AND UNDERWENT A PROCEDURE TO REMOVE THE LEADS. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS AND RECOVERED WELL POSTOPERATIVELY. DEVICE ANALYSIS WAS NOT PERFORMED BECAUSE THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY.

  Patient problems: Bacterial Infection; Impaired Healing; Wound Dehiscence

  MAUDE report 25894152 ↗

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