LinearRecalls & 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
- 62
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 2 models of Linear by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2017 and Mar 9, 2026 — classified as 52 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (24 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 problems
Device problems
- Unexpected Therapeutic Results24
- High impedance19
- Migration18
- Adverse Event Without Identified Device or Use Problem11
- Fracture6
- Migration or Expulsion of Device3
- Bent1
- Charging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Inadequate Pain Relief16
- No Code Available14
- Pain6
- No Known Impact Or Consequence To Patient5
- No Information3
- Cerebrospinal Fluid Leakage1
- Discomfort1
Linear models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Linear™ SC-2158-50STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF39 reports
- Linear™ SC-2158-70STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF23 reports
Recent Linear adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026High impedance; Unexpected Therapeutic Results; Charging Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION AND HIGH IMPEDANCES WERE NOTED ON BOTH SPINAL CORD STIMULATOR (SCS) LEADS. IT WAS ALSO STATED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT HOLDING A CHARGE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS AND IPG WERE REPLACED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Patient problems: Pain
MAUDE report 24544007 ↗InjuryJan 19, 2026Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND THE LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.
Patient problems: Pain
MAUDE report 24110367 ↗InjuryDec 4, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND DISPOSED OF PER HOSPITAL POLICY. NO DEVICE MALFUNCTION WAS SUSPECTED.
Patient problems: Pain
MAUDE report 23719157 ↗InjurySep 9, 2025Migration; Migration
IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005356 ↗InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172320 ↗InjuryApr 23, 2025High impedance; High impedance
IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896120 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS CONTINUALLY KEPT PUSHING THROUGH THE PATIENTS SKIN. THE PHYSICIAN GRABBED SOME SCISSORS AND CLIPPED THE LEAD AT THE SKULL.
Patient problems: Erosion
MAUDE report 21114395 ↗InjuryDec 31, 2024High impedance; High 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 KEPT BY THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21049071 ↗InjuryJul 24, 2024High impedance; High impedance
IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE LEADS REMAIN IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823282 ↗InjuryJul 16, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE LEADS WERE CAUSING PAIN IN THE PATIENTS BACK. IT WAS ALSO NOTED THAT THE SPINAL CORD STIMULATION (SCS) WAS NOT HELPING WITH THE PATIENTS PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.
Patient problems: Implant Pain; Pain
MAUDE report 19751201 ↗InjuryJun 21, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO MIGRATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19588308 ↗InjuryJun 21, 2024High impedance; Unexpected Therapeutic Results; Migration; High impedance; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND HIGH IMPEDANCE READINGS WERE DISCOVERED ON THE LEAD. ADDITIONALLY, IMAGING THAT WAS TAKEN CONFIRMED THAT THE LEAD HAD MIGRATED. REPROGRAMMING DID NOT RESOLVE THE INADEQUATE STIMULATION. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 19586786 ↗InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711189 ↗InjuryAug 7, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS NOT RELEASED BY THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467938 ↗InjuryJan 10, 2023Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LINEAR LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Inadequate Pain Relief
MAUDE report 16130475 ↗
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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