Linear™ SC-2158-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729767718), received between May 22, 2017 and Jan 19, 2026 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 24, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENTS LEADS WERE EXPLANTED WHEREIN THE LEFT CERVICAL LEADS DISTAL TIP WERE LEFT BEHIND. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663950 ↗
• InjurySep 30, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE OLD LEADS WERE REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) CAPABLE ONE AND WERE MOVED HIGHER. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEADS WERE DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15514758 ↗
• InjurySep 6, 2022Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS WERE ADDED FOR AN UNKNOWN REASON.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366723 ↗
• InjuryAug 1, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENTS LEADS IN THE CERVICAL AREA WERE NOT GETTING COVERAGE ON THE LEFT DUE TO LOCATION ON THE FAR RIGHT. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND REPOSITIONED AT THE MIDLINE. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER PHYSICIAN PREFERENCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15141964 ↗
• InjuryJun 15, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14698271 ↗
• InjuryAug 6, 2021High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ANY STIMULATION DUE TO LEADS WERE NO LONGER WORKING AND HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT LEADS REPLACEMENT PROCEDURE AND WAS DOING GOOD POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12289016 ↗
• MalfunctionJul 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER A NON-DEVICE RELATED SURGERY, THE PATIENTS LEADS HAVE BEEN CUT OR DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED THAT AN ELECTROCAUTERY WAS USED DURING THE NON-DEVICE RELATED SURGERY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201903 ↗
• InjuryJun 18, 2021Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028472 ↗
• InjuryJun 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935927 ↗
• InjuryFeb 7, 2020Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9684087 ↗
• InjurySep 6, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8970299 ↗
• InjuryMar 29, 2019Migration; Migration

  A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8465678 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

  Patient problems: No Code Available

  MAUDE report 7767783 ↗
• InjuryMay 10, 2018Fracture; Fracture

  A REPORT WAS RECEIVED THAT THE PATIENT HAD A FRACTURED LEAD. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7505204 ↗
• MalfunctionMay 22, 2017Bent; Fracture; High impedance; Kinked; Migration or Expulsion of Device; Bent; Fracture; High impedance; Kinked; Migration or Expulsion of Device

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOST OF COVERAGE. IT WAS ALSO REPORTED THAT THE LEADS HAD MIGRATED AND A LEAD WAS HAVING FOUR CONTACTS OUT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS AND CLICK ANCHORS WERE REPLACED. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6583469 ↗

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-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-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-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-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-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.