Linear STRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,068
- Deaths reported
- 3
- Injuries reported
- 3,776
- Recalls
- 0
We found 5 models of Linear ST by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 4,068 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 30, 2026 — classified as 3 deaths, 3,776 injuries, 289 malfunctions.
The most frequently reported specific device problem is “Migration” (1,911 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 ST problems
Device problems
- Migration1,911
- Unexpected Therapeutic Results1,896
- High impedance886
- Adverse Event Without Identified Device or Use Problem853
- Fracture261
- Inappropriate/Inadequate Shock/Stimulation71
- Migration or Expulsion of Device54
- Charging Problem44
Patient problems
- Pain1,100
- No Clinical Signs, Symptoms or Conditions981
- No Code Available917
- Inadequate Pain Relief547
- Undesired Nerve Stimulation309
- Bacterial Infection129
- Discomfort128
- No Known Impact Or Consequence To Patient106
Linear ST models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Linear™ ST SC-2218-50STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2,729 reports
- Linear™ ST SC-2218-70STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,175 reports
- Linear™ ST SC-2218-50ESTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths135 reports
- Linear™ ST SC-2218-70ESTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death26 reports
- Linear™ ST SC-2218-30STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF3 reports
Recent Linear ST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture; High impedance; Off-Label Use
It was reported that during an Implantable Pulse Generator (IPG) revision procedure (MFR 3006630150-2026-06185), the remote control indicated high impedances across the entire lead. Following completion of the procedure, the physician reviewed the patient's chart and identified that one of the leads was fractured and completely severed. No additional information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942036 ↗InjurySep 29, 2026Unexpected Therapeutic Results
It was reported that the patient was not getting good leg coverage along with back coverage. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted products were discarded per hospital policy.
Patient problems: Pain
MAUDE report 50928371 ↗InjurySep 28, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917395 ↗InjurySep 28, 2026High impedance
It was reported that the Spinal Cord Stimulator (SCS) leads of the patient had impedances. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted devices were not returned as the facility discarded the devices.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915505 ↗InjurySep 25, 2026Unexpected Therapeutic Results; Migration
Patient problems: Pain
MAUDE report 50904252 ↗InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903115 ↗InjurySep 25, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900174 ↗InjurySep 24, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892268 ↗InjurySep 24, 2026Unexpected Therapeutic Results; Migration
Patient problems: Pain
MAUDE report 50891654 ↗InjurySep 24, 2026Unexpected Therapeutic Results; Battery Problem; Migration
Patient problems: Burning Sensation; Numbness; Pain; Paresthesia; Swelling/ Edema
MAUDE report 50886568 ↗InjurySep 22, 2026Unexpected Therapeutic Results; Migration
Patient problems: Pain
MAUDE report 50862904 ↗InjurySep 22, 2026Unexpected Therapeutic Results; Migration
It was reported that the patients stimulation therapy was not adequately targeting the areas requiring pain relief. It was noted that the leads had migrated which was confirmed through imaging. Program optimization was performed, and the Spinal Cord Stimulator (SCS) device was functioning as intended. The patient underwent a procedure wherein an additional SCS lead was implanted. The patient was reported to be doing well postoperatively. The devices remain implanted and in use.
Patient problems: Pain
MAUDE report 50858981 ↗InjurySep 22, 2026Migration
It was reported that the patient's Spinal Cord Stimulation (SCS) leads had moved down. The patient underwent Spinal Cord Stimulator (SCS) replacement procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858218 ↗InjurySep 22, 2026High impedance
It was reported that the patient was experiencing high impedance on the spinal cord stimulator (SCS) lead after a non-device related fall. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted lead was discarded by the medical facility and will not be returned.
Patient problems: Fall
MAUDE report 50857045 ↗InjurySep 22, 2026Packaging Problem
It was reported that the patient became ill and was vomiting the patient was under anesthesia.
Patient problems: Vomiting
MAUDE report 50851480 ↗
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
- Infinion CX2 models · 2,139 reports · 1 recall
- Superion5 models · 1,488 reports · 2 recalls
- Infinion 165 models · 1,550 reports
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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