Linear™ ST SC-2218-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,175 adverse event reports that list this exact device (DI 08714729767749), received between Dec 12, 2016 and Sep 30, 2026 — classified as 1,085 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (545 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 1,175 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture; High impedance; Off-Label Use

  It was reported that during an Implantable Pulse Generator (IPG) revision procedure (MFR 3006630150-2026-06185), the remote control indicated high impedances across the entire lead. Following completion of the procedure, the physician reviewed the patient's chart and identified that one of the leads was fractured and completely severed. No additional information was available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942036 ↗
• InjurySep 28, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917395 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results; Migration

  Patient problems: Pain

  MAUDE report 50904252 ↗
• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900174 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results; Migration

  Patient problems: Pain

  MAUDE report 50891654 ↗
• InjurySep 22, 2026High impedance

  It was reported that the patient was experiencing high impedance on the spinal cord stimulator (SCS) lead after a non-device related fall. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted lead was discarded by the medical facility and will not be returned.

  Patient problems: Fall

  MAUDE report 50857045 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing an increased muscle spasm in her trapezius muscles after a fall. The patient had a trigger point injections.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 50850593 ↗
• MalfunctionSep 18, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Migration

  Patient problems: Ambulation or Postural Difficulties; Fall; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50829156 ↗
• InjurySep 18, 2026High impedance; Unexpected Therapeutic Results

  It was reported that the patient had device interrogation and revealed failed contacts. Due to high impedances, the patient's areas of pain could not be stimulated. Consequently, the patient underwent a Spinal Cord Stimulator (SCS) replacement procedure.

  Patient problems: Pain

  MAUDE report 50820689 ↗
• InjurySep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780613 ↗
• InjurySep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779968 ↗
• InjurySep 15, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient was experiencing abdominal stimulation from lead migration and patient can no longer turned it on. The patient underwent spinal cord stimulation (SCS) explant procedure.

  Patient problems: Abdominal Pain; Inappropriate Device Stimulation of Tissue

  MAUDE report 50775090 ↗
• InjurySep 8, 2026Unexpected Therapeutic Results

  Patient problems: Insufficient Information; Pain

  MAUDE report 50679619 ↗
• InjuryAug 11, 2026Unexpected Therapeutic Results; Migration

  It was reported that the spinal cord stimulation (SCS) patient experienced a complete loss of coverage and did not feel any stimulation on the right side during a reprogramming session. The physician stated that the leads appeared to be slightly toward the left side. A X-ray was performed and confirmed the lead migration. The patient underwent a revision procedure due to administrative reasons. During the procedure, the implanted leads were surgically exposed and inspected. An attempt was made to reposition the previously implanted the lead, however, adequate stimulation coverage was not achieved. The physician attempted to advance and implant a new lead, but the attempt was unsuccessful. Two existing leads were repositioned, resulting in improved stimulation coverage. No leads were explanted during the procedure. Improved stimulation coverage was achieved following lead repositioning. The patient was doing well postoperatively and no procedural conditions were reported.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 50216997 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's implantable pulse generator (IPG) and spinal cord stimulator (SCS) lead were explanted due to an unknown reason. The patient was doing well postoperatively and the explanted devices were discarded by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114333 ↗
• InjuryJul 28, 2026Unexpected Therapeutic Results

  It was reported that a patient with a spinal cord stimulation (SCS) device experienced inadequate therapy associated with suboptimal lead placement. The patient subsequently underwent a revision procedure during which the lead was explanted and replaced in the desired location. The explanted lead was discarded and is not expected to be returned for analysis. The patient is doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50059012 ↗
• InjuryJul 22, 2026Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED AFTER RECEIVING THE END OF LIFE MESSAGE. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906561 ↗
• InjuryJul 16, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A FALL. THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT AND LEADS REPOSITIONING PROCEDURE. PATIENT WAS PROGRAMMED WELL. THE FACILITY DISPOSED OF THE OLD IPG.

  Patient problems: Fall; Pain

  MAUDE report 25850504 ↗
• InjuryJul 16, 2026High impedance; Unexpected Therapeutic Results; Positioning Problem

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES AND THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. 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; Pain

  MAUDE report 25841690 ↗
• InjuryJul 9, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT NEEDED THE PERCUTANEOUS LEADS TO BE REPLACED WITH A PADDLE LEAD IN THE HOPES OF GETTING BETTER BACK COVERAGE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Pain

  MAUDE report 25773170 ↗
• InjuryJun 26, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT X-RAY REVEALED THAT PATIENTS LEAD HAD MIGRATED AFTER TRIPPING OVER HER DOG AND HAD AN INADEQUATE STIMULATION AS A RESULT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 25638407 ↗
• InjuryJun 26, 2026High impedance; Nonstandard Device; Unexpected Therapeutic Results

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SPINAL CORD STIMULATION (SCS) SYSTEM EXPERIENCED A LOSS OF THERAPY ATTRIBUTED TO HIGH IMPEDANCE AND DAMAGE TO THE LEADS. TROUBLESHOOTING EFFORTS, INCLUDING REPROGRAMMING, WERE PERFORMED BUT WERE NOT SUCCESSFUL. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEADS AND CLIK ANCHORS WERE REPLACED. IT WAS NOTED THAT THE CLIK ANCHORS HAD BEEN SIGNIFICANTLY TRIMMED BY THE SURGEON. POSTOPERATIVELY, THE PATIENT WAS EVALUATED FOR DEVICE PROGRAMMING AND SUBSEQUENTLY ACHIEVED EFFECTIVE COVERAGE OF THE PAINFUL AREA.

  Patient problems: Pain

  MAUDE report 25636478 ↗
• InjuryJun 16, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE.

  Patient problems: Pain

  MAUDE report 25526656 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459239 ↗
• MalfunctionJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CERVICAL IMPLANT PROCEDURE, THE PATIENT WENT CODE BLUE FOR ABOUT FIVE MINUTES IN. IT WAS NOTED THAT THE PHYSICIAN WAS ABOUT ONE MINUTE INTO HIS FIRST INCISION WHEN THE PATIENT WAS CODED. THE PHYSICIAN BELIEVED IT WAS DUE TO ANESTHESIA. NO PRODUCT WAS IMPLANTED HENCE THE DEVICE WAS IN NO WAY RELATED TO THE CODE. THE PATIENT WAS REPORTEDLY DOING FINE. THE FACILITY DISCARDED THE OPENED LEAD KIT.

  Patient problems: Cardiac Arrest

  MAUDE report 25385180 ↗

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-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-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-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-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-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.