ArtisanRecalls & reported problems across all models

We found 2 models of Artisan by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 875 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Sep 30, 2026 — classified as 773 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (290 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 Artisan problems

Artisan models

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

• Artisan™ SC-8216-50

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  451 reports
• Artisan™ SC-8216-70

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  424 reports

Recent Artisan 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

  It was reported by a patient advocate that the patient was experiencing a medical emergency and was admitted to the hospital for stroke evaluation. The patient was incoherent and recently fell but not on the spinal cords stimulation (SCS) implant. The patient hasn't used the stimulator in sometime but could not recall approximated time and reason. However, the patient was in need of an urgent MRI.

  Patient problems: Fall; Stroke/CVA

  MAUDE report 50942054 ↗
• InjurySep 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892212 ↗
• InjurySep 24, 2026Migration

  It was reported that the Spinal Cord Stimulator (SCS) paddle lead of the patient came out of the epidural space. The patient underwent a SCS paddle lead revision procedure. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888540 ↗
• InjurySep 24, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient was only feeling stimulation when tilting neck to the right and strong jolts when moving the arms. It was also stated that the patient's spinal cord stimulator (SCS) paddle leads had high impedance. The patient underwent a procedure wherein the IPG and paddle leads were replaced.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50878646 ↗
• InjurySep 23, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875618 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient had a stroke, broke the hip and it was decided to explant the system for unknown reasons. No further information has been obtained.

  Patient problems: Stroke/CVA; Unspecified Tissue Injury

  MAUDE report 50793073 ↗
• InjurySep 15, 2026High impedance

  It was reported that the lead had high impedances. The patient underwent lead replacement procedure. The patient was stable postoperatively. The explanted leads was disposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774128 ↗
• InjuryAug 28, 2026Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration

  It was reported that the paddle had shifted position. During the paddle adjustment procedure, a contact became loose. As a result, the entire paddle assembly was replaced. The old paddle remains at the facility per facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50506248 ↗
• InjuryAug 28, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient experienced inadequate pain relief. The patient felt a pop and per physician the paddle Spinal Cord Stimulation (SCS) lead had migrated as confirmed via imaging. The patient underwent Spinal Cord Stimulator (SCS) explant procedure and was doing well postoperatively. All explanted device components were not released by the facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50501360 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient was intubated at the hospital and needed an MRI scan to rule out stroke. The patient was then transferred to the hospice unit. There was no suspected adverse event related to the stimulation.

  Patient problems: Stroke/CVA

  MAUDE report 50419146 ↗
• InjuryAug 7, 2026Migration

  It was reported that the patients Spinal Cord Stimulator (SCS) paddle lead had migrated, and this was confirmed through imaging. As a result, the patient underwent an SCS paddle lead replacement procedure and was doing well postoperatively. The explanted device was not able to be returned due to hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183838 ↗
• InjuryAug 4, 2026High impedance

  It was reported that the patients lead had high impedances. The patient underwent a lead and Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device components were not returned by the medical facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136112 ↗
• InjuryJul 31, 2026Migration

  It was reported that the Spinal Cord Stimulator (SCS) paddle lead of the patient was pulled out of the space. The device migration was confirmed thru x-ray imaging. The patient underwent a SCS paddle lead repositioning procedure. The device remained implanted and in service. No further information has been obtained.Additional information was received that the patient doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101567 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO NUMBNESS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Numbness

  MAUDE report 25893757 ↗
• InjuryJul 21, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS PADDLE LEAD REVISION, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISPOSED OF BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892736 ↗

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