Linear™ 3-4 SC-2352-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 313 adverse event reports that list this exact device (DI 08714729789581), received between Dec 22, 2016 and Sep 30, 2026 — classified as 292 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (127 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 313 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 30, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS IN THE ABDOMEN WHEN THE DEVICE WAS TURNED ON AND OFF. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS NOT FUNCTIONING AFTER A FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE NOT RELEASED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: Device Overstimulation of Tissue; Fall; Pain

  MAUDE report 25053336 ↗
• InjuryApr 17, 2026Nonstandard Device

  IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS WAS CUT DURING A NON DEVICE RELATED PROCEDURE. THE LEADS REMAIN IMPLANTED IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910229 ↗
• InjuryMar 30, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24716624 ↗
• InjuryMar 9, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO IMPEDANCES DISPLAYED ON THE SPINAL CORD STIMULATION (SCS) LEAD. THEREFORE, THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24554226 ↗
• MalfunctionFeb 24, 2026Fracture

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD A FRACTURE. DEVICE FRACTURE WAS CONFIRMED THRU X-RAY IMAGING. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS CHECKED FOR IMPEDANCES AND EVERYTHING WERE WITHIN NORMAL LIMITS. THE PATIENT WAS REPROGRAMED AND ALL PAIN AREAS WERE COVERED. THE DEVICES REMAINED IMPLANTED AND IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430560 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INCISION SITE OF THE PATIENT WOULD NOT HEAL WELL DUE TO AN INFECTION THAT HAD DEVELOPED. THE PATIENT WAS HOSPITALIZED AND WAS PROVIDED A COURSE OF ANTIBIOTICS, WOUND WASH AND WOUND VACUUM. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND HAD RECOVERED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Bacterial Infection; Impaired Healing

  MAUDE report 24430129 ↗
• InjuryFeb 23, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A SCS LEAD REVISION AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Pain

  MAUDE report 24414389 ↗
• InjuryFeb 19, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF PAIN COVERAGE FROM THE SPINAL CORD STIMULATION (SCS) LEAD. AN X-RAY IDENTIFIED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS ATTEMPTED TO BE MOVED BACK TO THE OLD POSITION; HOWEVER, DUE TO TOO MUCH SCARRING ON THE LEAD, THE LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED. THE LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24395383 ↗
• InjuryFeb 10, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-DEVICE RELATED SEVERE SLIPPING MOVEMENT WITH A SEVERE TWIST IN HIS BODY. OVER TIME, THE PAIN-RELIEVING EFFECT OF HIS SCS IMPLANT DIMINISHED, AND ALL LEAD IMPEDANCES WERE FOUND TO BE ELEVATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND REGAINED PAIN RELIEF POSTOPERATIVELY.

  Patient problems: Fall; Pain

  MAUDE report 24310829 ↗
• InjuryJan 12, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE-RELATED FALL AND TWO WEEKS LATER EXPERIENCED LESS EFFECTIVE STIMULATION. IT WAS THEN FOUND DURING A CHECK-UP THAT THE LEAD DISPLAYED MULTIPLE HIGH IMPEDANCES, AND THE IPG DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PHYSICIAN SUSPECTED THAT THE HIGH IMPEDANCES MAY HAVE RESULTED IN THE ERI. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Fall; Pain

  MAUDE report 24047721 ↗
• InjuryDec 23, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFICIENT PAIN THERAPY. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED; THE LEAD REMAINS IMPLANTED AND IN USE. AN ADDITIONAL LEAD WAS ADDED FOR BETTER PAIN COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 23885254 ↗
• InjuryDec 22, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT MULTIPLE HIGH IMPEDANCES WERE IDENTIFIED DURING REPROGRAMMING OF THE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM AND THAT THE PATIENT LOST STIMULATION COVERAGE OF THEIR RIGHT SIDE. MULTIPLE PROGRAMMING SESSIONS WERE PERFORMED, HOWEVER THE HIGH IMPEDANCES WERE NOT RESOLVED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEAD WITH THE HIGH IMPEDANCES WAS EXPLANTED AND REPLACED WITH A NEW LEAD, AND IS RECOVERING POST OPERATIVELY. IT IS UNKNOWN WHICH OF THE TWO IMPLANTED LEADS WAS EXPLANTED, IT WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 23873588 ↗
• InjuryDec 22, 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 DEVELOPED REDNESS AT THE SACRUM AND A MINOR INFECTION AT THE LEAD ENTRY POINT. AS A RESULT, THE PATIENT UNDERWENT A LEAD EXPLANT AND WAS PLACED ON ANTIBIOTICS. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE. POSTOPERATIVELY, THE PATIENT IS DOING WELL. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 23873374 ↗
• InjuryDec 16, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT FELL AND THE SPINAL CORD STIMULATION (SCS) LEAD MIGRATED, RESULTING IN A LOSS OF STIMULATION COVERAGE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. THE PHYSICIAN ASSESSED THAT THERE WAS NO OTHER ISSUE WITH THE LEAD. THE PATIENT WAS HEALING POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Fall; Inadequate Pain Relief

  MAUDE report 23823982 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED BLEEDING DUE TO THE WOUND SITE REOPENING AFTER FAILING TO HEAL. AN URGENT RE-SUTURE WAS PERFORMED TO CLOSE THE WOUND. NO DEVICES WERE REMOVED OR ADDED, AND THE IPG REMAINS IMPLANTED. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Wound Dehiscence

  MAUDE report 23697044 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TO UNDERGO A SPINAL CORD STIMULATION (SCS) LEAD IMPLANT PROCEDURE. THE PROCEDURE BEGAN WITH THE ADMINISTRATION OF ANALGESIC SEDATION, FOLLOWED BY FLUOROSCOPIC IMAGING. DURING THE LEAD PLACEMENT, THE PATIENT EXPERIENCED SYNCOPE AND STOPPED BREATHING. SPONTANEOUS BREATHING DID NOT RETURN; THEREFORE, THE LEAD AND INSERTION NEEDLE WERE REMOVED. THE PATIENT WAS POSITIONED SUPINE, INTUBATED, AND PROVIDED ANESTHETIC TREATMENT. ONCE STABILIZED, THE PROCEDURE WAS CONCLUDED WITH PROPER WOUND CLOSURE AND DISINFECTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL A FEW DAYS LATER. THERE WAS NO PRE-EXISTING MEDICAL CONDITION THAT COULD BE ATTRIBUTED TO THIS INCIDENT. THE PATIENT WAS REFERRED TO A PULMONOLOGIST TO CHECK HER ALLERGY STATUS. THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Loss of consciousness; Respiratory Arrest; Syncope/Fainting

  MAUDE report 23688263 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED EDEMA AT THE DISTAL TIP OF ONE OF THE LEADS, ACCOMPANIED BY TENDERNESS, SWELLING LOCATED AT THE LEFT EYEBROW OUTER CORNER. DRAINAGE WAS SUCCESSFULLY PERFORMED, AND THE PATIENT WAS DOING WELL. IT IS SUSPECTED THAT THE CAUSE OF LEAD EDEMA WAS FRICTION/IRRITATION FROM THE TIP OF THE LEAD.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 23639323 ↗
• InjuryNov 21, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEADS WERE REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT'S DEVICE WAS SUCCESSFULLY PROGRAMMED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619018 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AROUND THE SPINAL CORD STIMULATION LEAD SITE. THE PHYSICIAN DOES NOT FEEL THE PAIN IS DEVICE RELATED, HOWEVER DOES NOT KNOW THE REASON FOR THE PAIN. THE PATIENT WAS REFERRED FOR PAIN INJECTIONS. THERE WILL BE NO FURTHER COURSE OF ACTION.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 23413991 ↗

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-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-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-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-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-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-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-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.