Linear™ ST SC-2218-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,729 adverse event reports that list this exact device (DI 08714729767725), received between Dec 8, 2016 and Sep 29, 2026 — classified as 2,536 injuries, 193 malfunctions.

The most frequently reported specific device problem is “Migration” (1,358 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 2,729 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Unexpected Therapeutic Results

  It was reported that the patient was not getting good leg coverage along with back coverage. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted products were discarded per hospital policy.

  Patient problems: Pain

  MAUDE report 50928371 ↗
• InjurySep 28, 2026High impedance

  It was reported that the Spinal Cord Stimulator (SCS) leads of the patient had impedances. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted devices were not returned as the facility discarded the devices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915505 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903115 ↗
• InjurySep 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892268 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results; Battery Problem; Migration

  Patient problems: Burning Sensation; Numbness; Pain; Paresthesia; Swelling/ Edema

  MAUDE report 50886568 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Migration

  Patient problems: Pain

  MAUDE report 50862904 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patients stimulation therapy was not adequately targeting the areas requiring pain relief. It was noted that the leads had migrated which was confirmed through imaging. Program optimization was performed, and the Spinal Cord Stimulator (SCS) device was functioning as intended. The patient underwent a procedure wherein an additional SCS lead was implanted. The patient was reported to be doing well postoperatively. The devices remain implanted and in use.

  Patient problems: Pain

  MAUDE report 50858981 ↗
• InjurySep 22, 2026Migration

  It was reported that the patient's Spinal Cord Stimulation (SCS) leads had moved down. The patient underwent Spinal Cord Stimulator (SCS) replacement procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858218 ↗
• InjurySep 22, 2026Packaging Problem

  It was reported that the patient became ill and was vomiting the patient was under anesthesia.

  Patient problems: Vomiting

  MAUDE report 50851480 ↗
• InjurySep 21, 2026High impedance

  It was reported that three lead contacts were out of range. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure and was doing well postoperatively. The explanted products were discarded per hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835265 ↗
• InjurySep 18, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50831457 ↗
• InjurySep 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831261 ↗
• InjurySep 18, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829230 ↗
• InjurySep 18, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient underwent a revision because patient wasnt getting relief in her new pain areas. The patient was reported to be receiving good coverage of the pain areas postoperatively and was scheduled for follow-up with the local representative. The explanted Montage IPG was discarded by the facility and was not returned for analysis.

  Patient problems: Pain

  MAUDE report 50819543 ↗
• InjurySep 17, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain along midline spine, as well as burning and numbness in the thoracic spine. The patient also reported the need to frequently recharge the Implantable Pulse Generator (IPG) and required Magnetic Resonance Imaging (MRI). Due to the reported symptoms, the patient had pain medication.

  Patient problems: Burning Sensation; Numbness; Pain

  MAUDE report 50807019 ↗
• InjurySep 16, 2026Adverse 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 replaced device is unknown. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790106 ↗
• MalfunctionSep 16, 2026Migration

  It was reported that the patient was experiencing a stimulation in the unwanted areas due to a lead that migrated that was confirmed via X-ray.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50784156 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion

  MAUDE report 50779903 ↗
• InjurySep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779699 ↗
• InjurySep 15, 2026Migration

  It was reported that the patients leads had migrated. The patient underwent a revision procedure during which the leads were repositioned to the desired location.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779645 ↗
• InjurySep 15, 2026Device Dislodged or Dislocated

  It was reported that the physician was having difficulty inserting the lead due to patient's anatomy during a spinal cord stimulation (SCS) implant procedure. There were three most proximal contacts detached from the lead when the physician attempted to insert the lead multiple times. The lead was not implanted to the patient's body and all contacts were removed. The patient was doing well postoperatively and lead was discarded by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769602 ↗
• InjurySep 15, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 50766031 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765711 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's legs had given out and experienced several episodes of losing balance over the past few days. The physician indicated that these symptoms might be related to the patient's other health conditions. The patient went to the Emergency Room (ER) for further evaluation, including thoracic and lumbar MRI imaging. The patient was reported to be doing well.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy

  MAUDE report 50753869 ↗
• InjuryAug 18, 2026Migration

  It was reported that one of the patients spinal cord stimulation (SCS) lead had migrated. The patient underwent a lead revision procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308222 ↗

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-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-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-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.