Linear 3-4Recalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 591
- Deaths reported
- 1
- Injuries reported
- 536
- Recalls
- 0
We found 3 models of Linear 3-4 by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 591 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Sep 30, 2026 — classified as 1 death, 536 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (239 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 Linear 3-4 problems
Device problems
- Unexpected Therapeutic Results239
- Migration235
- Adverse Event Without Identified Device or Use Problem158
- High impedance117
- Fracture51
- Inappropriate/Inadequate Shock/Stimulation10
- Device Dislodged or Dislocated9
- Use of Device Problem7
Patient problems
- Pain140
- No Code Available132
- No Clinical Signs, Symptoms or Conditions130
- Inadequate Pain Relief86
- Undesired Nerve Stimulation48
- Unspecified Infection27
- Bacterial Infection24
- No Known Impact Or Consequence To Patient21
Linear 3-4 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Linear™ 3-4 SC-2352-70STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF313 reports
- Linear™ 3-4 SC-2352-50STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF268 reports
- Linear™ 3-4 SC-2352-50ESTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death10 reports
Recent Linear 3-4 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Inappropriate Device Stimulation of Tissue; Pain
MAUDE report 50954698 ↗InjurySep 30, 2026Unexpected Therapeutic Results; Migration
It was reported that the patient experienced a change in coverage and relief due to the Spinal Cord Stimulator (SCS) leads were twisted. It was noted that there was nothing specific that occurred to cause the leads to migrate. The patient underwent a SCS lead replacement procedure and was doing well postoperatively. Nothing was returned due to facility policy.
Patient problems: Pain
MAUDE report 50947879 ↗InjurySep 30, 2026Unexpected Therapeutic Results; Migration
It was reported that the patient's Spinal Cord Stimulation (SCS) leads had migrated, as confirmed by fluoroscopic imaging. As a result, the therapy no longer provided adequate pain coverage. The physician indicated that the patient's prior non-device related back surgery may have been a contributing factor to the lead migration. The patient underwent lead replacement and used click anchor to help prevent migration. The patient was doing well postoperatively, and the explanted devices were disposed. No device malfunction was suspected.
Patient problems: Pain
MAUDE report 50947143 ↗InjurySep 25, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906089 ↗InjuryAug 21, 2026High impedance
It was reported that the patients spinal cord stimulation (SCS) leads had high impedances. The patient underwent a lead replacement along with a battery swap. The patient was doing well postoperatively. The explanted devices were not available for returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360694 ↗InjuryAug 18, 2026High impedance
It was reported that one of the patient's spinal cord stimulator (SCS) lead had high impedance. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted lead was retained by the medical facility and will not be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302854 ↗InjuryJul 28, 2026Nonstandard Device; Unexpected Therapeutic Results; Migration
It was reported that the spinal cord stimulation (SCS) patient presented with inadequate stimulation, described as insufficient pain relief in the targeted area. Evaluation determined that lead migration had occurred, resulting in the leads overlapping each other and contributing to the loss of coverage. Reprogramming was attempted several times with limited improvement. The patient underwent a revision procedure during which the existing leads were replaced with a paddle lead. During the same procedure, the implantable pulse generator (IPG) was replaced because the newly implanted paddle required a four port IPG. The explanted products were not released by the facility and were not returned for analysis. The patient is reported to be doing well postoperatively.
Patient problems: Pain
MAUDE report 50059941 ↗InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a spinal cord stimulation (SCS) patient was admitted to the hospital for evaluation following a stroke. It is unknown whether the stroke was related to the device, stimulation, or any other cause. Further information has not been provided.
Patient problems: Stroke/CVA
MAUDE report 25908446 ↗InjuryJul 22, 2026Unexpected Therapeutic Results; Battery Problem; Migration
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) LEAD MIGRATED FOLLOWING A MOTOR VEHICLE ACCIDENT. IT WAS ALSO STATED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED END OF LIFE DUE TO HIGH ENERGY USAGE SECONDARY TO LEAD MIGRATION. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED AND THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Patient problems: Pain
MAUDE report 25901388 ↗MalfunctionJul 6, 2026Fracture
IT WAS REPORTED THAT THE LEAD WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25721950 ↗InjuryJul 1, 2026Migration
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY.
Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions
MAUDE report 25682442 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEAD WAS INITIALLY POORLY POSITIONED. THE CLINICAL STUDY PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597963 ↗InjuryJun 12, 2026Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, MUSCLE WEAKNESS AND INEFFICIENT PAIN THERAPY FROM THEIR SPINAL CORD STIMULATOR (SCS). THE PATIENTS LEAD HAS MIGRATED. THE PATIENT UNDERWENT AN SCS REVISION PROCEDURE WHEREIN A LEAD WAS ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICE REMAINS IMPLANTED AND IN USE.
Patient problems: Muscle Weakness/Atrophy; Pain
MAUDE report 25492319 ↗InjuryMay 26, 2026Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT HAD A FALL AND EXPERIENCED STIMULATION ISSUES DUE TO LEAD MIGRATION. THE PHYSICIAN ASSESSED THE FALL AS NOT BEING RELATED TO THE DEVICE OR STIMULATION, AS THE PATIENT HAD OTHER HEALTH ISSUES. AN X-RAY WAS PERFORMED AND CONFIRMED THE LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT AND REPLACE THE TWO LEADS AND CLIK ANCHOR. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE PATIENT ALSO EXPERIENCED A LOSS OF COVERAGE DUE TO LEAD MIGRATION. THE ISSUE WAS RESOLVED AFTER THE REVISION. ALL EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL.
Patient problems: Fall; Pain
MAUDE report 25295129 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LEAD WAS REPLACED DUE TO AN UNKNOWN REASON. THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY, AND PATIENT WAS DOING WELL POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25272453 ↗
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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