Linear™ SC-2158-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729767695), received between Feb 6, 2017 and Mar 9, 2026 — classified as 32 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (14 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 39 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 18, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND THE EXPLANTED LEADS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001633 ↗
• InjuryDec 12, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS RIGHT LEAD HAD HIGH IMPEDANCES AND WAS UNABLE TO HAVE A MAGNETIC RESONANCE IMAGING (MRI). IT WAS ALSO NOTED THAT THE PATIENT STILL RECEIVED ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960500 ↗
• InjuryApr 15, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14120356 ↗
• InjuryFeb 23, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND ONE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS NOT RELEASED BY THE HOSPITAL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13584374 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SECOND STAGE IMPLANT PROCEDURE, ONE OF THE TWO PREVIOUSLY IMPLANTED LEADS WAS EXPLANTED AND REPLACED. IT IS UNCLEAR WHICH OF THE TWO LEADS WAS EXPLANTED AND WHICH REMAINED IMPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 12451557 ↗
• InjurySep 9, 2021High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ACHIEVE PAIN RELIEF OF THE TARGETED PAIN AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF A LEAD DUE TO INADEQUATE STIMULATION CAUSED BY HIGH IMPEDANCES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12444863 ↗
• InjuryJul 29, 2021Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12246315 ↗
• InjuryMar 10, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454993 ↗
• InjuryFeb 4, 2021Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENTS LEADS MIGRATED WHICH RESULTED TO INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LINEAR LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283209 ↗
• InjuryOct 20, 2020Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING PAIN AND INADEQUATE STIMULATION ON THE FOOT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS RECOVERING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

  Patient problems: No Code Available; Pain

  MAUDE report 10708493 ↗
• InjuryFeb 25, 2020Migration; Migration

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

  Patient problems: No Code Available

  MAUDE report 9751508 ↗
• MalfunctionFeb 6, 2020Fracture; Fracture

  A REPORT WAS RECEIVED THAT DURING THE PATIENTS IPG REVISION PROCEDURE (MFR 3006630150-2020-00322) THE LEAD WAS FRACTURED WHICH WAS A RESULT OF THE PHYSICIAN PULLING HARD TO REMOVE THE LEADS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675933 ↗
• InjuryAug 21, 2019Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8919027 ↗
• InjuryAug 2, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8855443 ↗
• InjuryApr 11, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT ONE OF 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 8504477 ↗
• MalfunctionApr 2, 2019High impedance; High impedance

  DEVICE ANALYSIS PERFORMED ON 2 RETURNED LEADS REVEALED THAT BOTH LEADS WERE FRACTURED: LEAD SC-2158-50, SN (B)(4) REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT KINKED LOCATION OF THE LEAD. THE BENT KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE CLIK SITE FRACTURE LOCATIONS. THE FRACTURED CABLES AT THE CLIK ANCHOR SITE RESULTED IN THE HIGH IMPEDANCES. LEAD SC-2158-50, SN (B)(4) REVEALED THAT THREE CABLES WERE COMPLETELY BROKEN AT THE BENT KINKED LOCATION OF THE LEAD. THE BENT KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE CLIK SITE FRACTURE LOCATION. THE FRACTURED CABLES AT THE CLIK ANCHOR SITE RESULTED IN THE HIGH IMPEDANCES.

  Patient problems: No Code Available

  MAUDE report 8475622 ↗
• InjuryMar 26, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8453875 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT PATIENT WAS HAVING IRRITATION AT INCISION SITE AND HAD A POSSIBLE SCABBING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE SYSTEM WAS REMOVED.

  Patient problems: Irritation; No Code Available

  MAUDE report 8402268 ↗

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-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-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-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-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.