Artisan MRIRecalls & reported problems across all models

We found 2 models of Artisan MRI by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 197 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2017 and Sep 23, 2026 — classified as 186 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (75 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 MRI problems

Artisan MRI models

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

• Artisan™ MRI SC-8416-50

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  108 reports
• Artisan™ MRI SC-8416-70

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

Recent Artisan MRI adverse event reports

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

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a staged trial while trying to access the cervical space, the patient lost some sensory function to right side of body, and the physician decided it was best to abort the case. No product was implanted. The lead will not be returned per hospital policy. No further information has been obtained despite good faith efforts.

  Patient problems: Insufficient Information

  MAUDE report 50864886 ↗
• InjuryJul 20, 2026Off-Label Use

  IT WAS REPORTED THAT FOLLOWING A CERVICAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS AND TINGLING IN THE UPPER AND LOWER EXTREMITIES. THE PHYSICIAN SUSPECTED HEMATOMA. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM AND UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

  Patient problems: Hematoma; Numbness; Paresthesia

  MAUDE report 25874099 ↗
• InjuryJul 7, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION FOLLOWING A FALL, WHICH WAS CONFIRMED THROUGH IMAGING STUDIES. UPON EVALUATION, THE PHYSICIAN OBSERVED THAT THE MIDLINE SPINAL INCISION APPEARED SUSPICIOUS, THOUGH NO EXTERNAL DRAINAGE WAS PRESENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FURTHER ASSESSMENT. DURING SURGICAL EXPLORATION OF THE SPINAL INCISION, SUSPICIOUS FLUID WAS ENCOUNTERED WITHIN THE MIDLINE INCISION CAVITY. BOTH SUPERFICIAL AND DEEP CULTURES WERE OBTAINED FOR ANALYSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS ADMITTED FOR INPATIENT CARE AND WILL BE INITIATED ON ANTIBIOTIC THERAPY. EXPLANTS DISCARDED PER FACILITY BIOHAZARD PROTOCOL.

  Patient problems: Bacterial Infection; Fluid Discharge; Pain; Wound Dehiscence

  MAUDE report 25740370 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE LOWER EXTREMITY PARALYSIS. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) PERFORMED THAT SHOWED BLEEDING AND THE PATIENT UNDERWENT EMERGENCY SURGERY TO EVACUATE A HEMATOMA ASSOCIATED WITH THE SCS PLACEMENT. THE EVENT WAS RELATED TO AN UNKNOWN BLOOD DISORDER. IT WAS NOTED THAT THE PATIENT WAS CURRENTLY IN STABLE CONDITION.

  Patient problems: Hematoma; Paralysis

  MAUDE report 24783580 ↗
• InjuryMar 30, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24714016 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED NODULES AND INFLAMMATION AROUND THE NECK DUE TO A NICKEL ALLERGY ON ONE OF THE IMPLANTED LEADS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 24553511 ↗
• InjuryMar 9, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542733 ↗
• InjuryNov 27, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND FEELING STRONG UNWANTED STIMULATION. THE SPINAL CORD STIMULATION (SCS) PADDLE MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 23665497 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE LEAD INCISION SITE AND WENT THE EMERGENCY ROOM. THE PATIENTS PAIN WAS DEEMED TO BE POSTOPERATIVE PAIN. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS DOING WELL.

  Patient problems: Implant Pain

  MAUDE report 23638234 ↗
• InjuryNov 4, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED, AND TWO NEW LEADS WERE ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23461864 ↗
• InjuryJul 18, 2025High impedance; Charging Problem; High impedance; Charging Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD HIGH IMPEDANCES. IT WAS ALSO REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543753 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PADDLE LEAD IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING LOWER EXTREMITY WEAKNESS AND WAS UNABLE TO MOVE THE LOWER EXTREMITIES. THE PHYSICIAN INSTRUCTED THE PATIENT TO BE TAKEN TO THE HOSPITAL.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22305262 ↗
• InjuryMay 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED TO BETTER COVER THE LEFT SIDE OF PAIN. THE LEAD REMAINS IMPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 22114725 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS BROKEN IN HALF WHICH WAS CONFIRMED THROUGH X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088036 ↗
• InjuryMay 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082709 ↗

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