Avista MRIRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 580
- Deaths reported
- 0
- Injuries reported
- 555
- Recalls
- 0
We found 2 models of Avista MRI by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 580 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Sep 26, 2026 — classified as 555 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Migration” (250 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
Reports received per month, all models
Most reported Avista MRI problems
Device problems
- Migration250
- Unexpected Therapeutic Results248
- Adverse Event Without Identified Device or Use Problem173
- High impedance62
- Fracture25
- Migration or Expulsion of Device13
- Inappropriate/Inadequate Shock/Stimulation10
- Defective Device7
Patient problems
- Pain165
- No Code Available132
- Inadequate Pain Relief87
- No Clinical Signs, Symptoms or Conditions87
- Undesired Nerve Stimulation51
- Discomfort34
- Bacterial Infection33
- Erosion22
Avista MRI models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Avista™ MRI SC-2408-56STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF441 reports
- Avista™ MRI SC-2408-74STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF139 reports
Recent Avista MRI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 26, 2026Migration
Patient problems: Fall
MAUDE report 50906489 ↗InjurySep 25, 2026Nonstandard Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906270 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was experiencing discomfort at the back while sitting. The patient is very thin, which likely contributed to the discomfort and prominence of the anchors. The patient underwent a procedure wherein the physician adjusted the underlying skin layers to provide additional cushioning over the anchors. The patient was doing well postoperatively.
Patient problems: Discomfort
MAUDE report 50899091 ↗InjurySep 21, 2026Migration
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50847125 ↗InjurySep 17, 2026Migration
It was reported that the patients spinal cord stimulator lead had migrated due to patient had a fall. Unknown if the fall was device related.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809448 ↗InjuryAug 18, 2026Positioning Problem; Migration
It was reported that the spinal cord stimulation (SCS) patient underwent a lead revision procedure due to significant lead migration requiring repositioning. The physician experienced challenges caused by scar tissue during the placement of the replacement leads; however, the leads were successfully implanted and the procedure was completed. During the same procedure, the physician elected to replace the implantable pulse generator (IPG). Patient postoperative status was not available at the time of reporting. The disposition of the explanted devices was not provided.
Patient problems: Scar Tissue
MAUDE report 50311740 ↗InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results; Migration
It was reported that the patient was experiencing pain. Upon interrogation, found one contact with an impedance and leads has also moved down a level which was confirmed with imaging. Program optimization was attempted and was unsuccessful. The patient underwent spinal cord stimulation (SCS) revision procedure. Patient was doing well postoperatively. The hospital kept the explanted products.
Patient problems: Pain
MAUDE report 50290571 ↗InjuryJul 27, 2026High impedance
It was reported that the leads had high impedances. The patient underwent a lead replacement procedure. Patient for coverage of pain area in recovery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037763 ↗MalfunctionJul 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s)
MAUDE report 25893618 ↗InjuryJun 19, 2026High impedance; Unexpected Therapeutic Results; Charging Problem; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION AND HAD A STIMULATION IN THE ABDOMINAL REGION DUE TO A CONFIRMED LEAD MIGRATION VIA X-RAY AND THE LEADS HAD HIGH IMPEDANCE.
Patient problems: Inappropriate Device Stimulation of Tissue; Pain
MAUDE report 25568246 ↗InjuryJun 17, 2026Unexpected Therapeutic Results; Low impedance
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT SOMETIMES EXPERIENCED INADEQUATE STIMULATION OR NO STIMULATION AT ALL. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT HAS FULLY RECOVERED AND WAS DOING WELL POSTOPERATIVELY.
Patient problems: Fall; Inadequate Pain Relief; Pain
MAUDE report 25538390 ↗MalfunctionJun 5, 2026Fracture
IT WAS REPORTED THAT THE DURING AN IMPLANT PROCEDURE, THE LEAD TAIL BROKE IN HALF WHEN THE PHYSICIAN WAS MOVING THE LEAD INTO THE MIDLINE INCISION. THE CAUSE WAS UNKNOWN AND NOTHING UNUSUAL DURING THE PROCEDURE. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417131 ↗InjuryMay 18, 2026High impedance
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER FACILITY POLICY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210936 ↗InjuryApr 11, 2026Unexpected Therapeutic Results
IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST OPERATIVELY.
Patient problems: Pain
MAUDE report 24848175 ↗InjuryMar 26, 2026High impedance; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEADS AND LEAD MIGRATION WHICH WAS CONFIRMED THROUGH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 24696118 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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