Linear™ 3-4 SC-2352-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 08714729789550), received between Dec 16, 2016 and Sep 30, 2026 — classified as 236 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (112 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 268 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 11, 2026High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849406 ↗
• InjuryMar 30, 2026Off-Label Use; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED ARM PAIN AT THE LEAD INCISION SITE AND REDUCED STIMULATION COVERAGE. AS A RESULT, THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE. POSTOPERATIVELY, THE PATIENT INITIALLY ACHIEVED EXCELLENT PAIN COVERAGE. SUBSEQUENTLY, THE PATIENT DEVELOPED FEVER AND AN ELEVATED WHITE BLOOD CELL COUNT DUE TO AN INFECTION AT THE ARM SITE WHERE THE PROCEDURE HAD BEEN PERFORMED, AND ANTIBIOTIC THERAPY WAS INITIATED. ACCORDING TO THE PHYSICIANS ASSESSMENT, THE INFECTION WAS RELATED TO THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD POSTOPERATIVE CARE, WHERE THE ENTIRE SCS SYSTEM WAS EXPLANTED, A WOUND WASHOUT WAS PERFORMED, AND CULTURES WERE OBTAINED. THE PATIENT HAS SINCE FULLY RECOVERED AND HAS BEEN DISCHARGED. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Fever; High White Blood Cell Count; Pain

  MAUDE report 24728580 ↗
• InjuryMar 26, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO INADEQUATE STIMULATION. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY AND PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24695843 ↗
• InjuryMar 19, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED BACK TO ITS ORIGINAL LOCATION AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24636312 ↗
• MalfunctionMar 11, 2026Fracture; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING STIMULATION ON HER LEFT SIDE. IMAGING REVEALED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD WAS FRACTURED.

  Patient problems: Pain

  MAUDE report 24568782 ↗
• InjuryMar 6, 2026High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO THE MIGRATION AND IMPEDANCE OF THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A SCS REVISION PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 24536987 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE SPINAL CORD STIMULATION (SCS) LEAD WITHIN THE EPIDURAL SPACE, AN INADVERTENT DURAL PUNCTURE OCCURRED, RESULTING IN CEREBROSPINAL FLUID (CSF) LEAKAGE. FOLLOWING IDENTIFICATION OF THE CSF LEAK, THE PATIENT REQUIRED ADMISSION BEYOND STANDARD POST PROCEDURE OBSERVATION. THE PATIENT EXPERIENCED POSITIONAL HEADACHE WHEN SITTING UPRIGHT AND IS BEING MANAGED CONSERVATIVELY WITH MONITORING AND BED REST TO SUPPORT POTENTIAL SPONTANEOUS CLOSURE OF THE PUNCTURE SITE. ACCORDING TO THE PHYSICIANS ASSESSMENT, THE COMPLICATION WAS DIRECTLY RELATED TO THE PROCEDURE, AND ANATOMICAL CONSTRAINTS WITHIN THE EPIDURAL SPACE LIMITED FURTHER LEAD ADVANCEMENT, ALLOWING PLACEMENT OF ONLY ONE SCS LEAD. THE PATIENT UNDERWENT A SUCCESSFUL EPIDURAL BLOOD PATCH PROCEDURE. THE DURAL PUNCTURE HAS SINCE RESOLVED, AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL WITH FULL CLINICAL RECOVERY AND NO FURTHER TREATMENT REQUIRED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 24475244 ↗
• InjuryFeb 18, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE SEVERAL ATTEMPTS OF OPTIMIZING THE PROGRAM. IMAGING CONFIRMED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: Pain

  MAUDE report 24383544 ↗
• InjuryFeb 18, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. 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 24382266 ↗
• InjuryJan 30, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DESPITE OF OPTIMIZING THE PROGRAM. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE LEADS REMAIN IMPLANTED AND IN USE.

  Patient problems: Pain

  MAUDE report 24222022 ↗
• InjuryJan 26, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED CHANGES IN STIMULATION AND WAS NO LONGER ACHIEVING PAIN RELIEF. AN X RAY REVEALED THAT THE LEAD HAD MIGRATED APPROXIMATELY TWO VERTEBRAL LEVELS DOWNWARD. SURGERY WAS PERFORMED TO REPOSITION THE LEAD; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL, AND THE LEAD WAS SUBSEQUENTLY REPLACED. POSTOPERATIVELY, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24185522 ↗
• InjuryJan 16, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT MEDICAL IMAGING CONFIRMED MIGRATION OF THE SPINAL CORD STIMULATION (SCS) LEAD FROM THE EPIDURAL SPACE, RESULTING IN INADEQUATE STIMULATION AND PATIENT PAIN. CONSEQUENTLY, THE LEAD WAS REPLACED, AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO ELECTIVELY REPLACED TO MITIGATE THE RISK OF INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24099524 ↗
• InjuryJan 16, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE LEADS REMAIN IMPLANTED AND IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094936 ↗
• InjuryJan 2, 2026High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY AND ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23947207 ↗
• InjuryDec 12, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ADEQUATE PAIN RELIEF IN THE AREA WHERE SHE NEEDED IT. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM, WHEREIN THE SPINAL CORD STIMULATION (SCS) LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 23789161 ↗
• InjuryNov 28, 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) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE EXPLANTED DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION INDICATES THAT THE SCS LEAD EXPLANT PROCEDURE DID NOT TAKE PLACE; THE DEVICE REMAINS IMPLANTED, AND NO ALLEGATIONS OR REPORTS OF DEVICE MALFUNCTION HAVE BEEN MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23674071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.