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

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 08714729784067), received between Dec 2, 2016 and Aug 17, 2026 — classified as 2 deaths, 130 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Tear, Rip or Hole in Device Packaging

  It was reported that the inner packaging of the trial lead was damaged, compromising the sterilization of it.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280361 ↗
• InjuryJul 22, 2026Migration

  It was reported that the lead had migrated. The patient underwent lead pull.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908058 ↗
• InjuryApr 30, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) TRIAL LEAD MIGRATION. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 25053307 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AROUND THE LEAD INSERTION SITE FOLLOWING THE TRIAL PROCEDURE. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS STABLE UPON FOLLOW-UP. THE REMOVED LEADS WERE NOT RETURNED.

  Patient problems: Bacterial Infection

  MAUDE report 24329537 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CHEST PAIN WHEN THE STIMULATION WAS ON. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. PATIENT IS DOING FINE POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Chest Pain; Undesired Nerve Stimulation

  MAUDE report 23790997 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEW PAIN IN THE UPPER RIGHT EXTREMITY WHEN THE THERAPY WAS TURNED OFF. PER THE PHYSICIAN, THE PATIENT HAD NERVE ROOT IRRITATION FROM THE PROCEDURE. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE AND REPORTED RELIEF OF THE NEW PAIN. THE PULLED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 23501336 ↗
• MalfunctionNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS TRIAL PROCEDURE WAS ABORTED AFTER THE PATIENT BECAME NAUSEOUS PRIOR THE PROCEDURE. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED. THE PATIENT WILL BE REFERRED TO A SURGEON FOR A PADDLE TRIAL.

  Patient problems: Nausea

  MAUDE report 23451592 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A SUSPECTED HEMATOMA FORMATION FOLLOWING A TRIAL PROCEDURE. THE PHYSICIAN BELIEVED THAT THE PATIENT'S SYMPTOMS WERE NOT DEVICE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) TRIAL LEADS WERE EXPLANTED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Hematoma

  MAUDE report 23448002 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE SPINAL CORD STIMULATOR (SCS) TRIAL PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT WAS HOSPITALIZED. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SCS TRIAL LEAD EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: Chest Pain

  MAUDE report 23102298 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE WHEN THE TRIAL PERIOD BEGAN. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. THE PATIENT STILL REPORTED DISCOMFORT AT THE SITE HOWEVER IS DOING WELL UPON FOLLOW-UP. THE REMOVED LEADS WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Implant Pain

  MAUDE report 22847035 ↗
• InjuryMar 21, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT A POTENTIAL SIGN OF INFECTION WAS NOTED FOLLOWING AN END OF TRIAL SPINAL CORD STIMULATOR (SCS) LEAD PULL PROCEDURE. THE EXPLANTED LEADS WERE DISCARDED.

  Patient problems: Bacterial Infection

  MAUDE report 21667972 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAINFUL SPASMS IN THE RIGHT LEG AND BUTTOCK AFTER THE TRIAL PROCEDURE PRIOR TO PROGRAMMING. THE PHYSICIAN ELECTED TO PULL THE TRIAL LEADS AND PATIENT WAS ADMINISTERED PAIN MEDICATION. THE PATIENT WAS REPORTEDLY FEELING BETTER ONCE THE LEADS WERE REMOVED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

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

  MAUDE report 21643221 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLEEDING AND WAS PRESCRIBED WITH MEDICATION. THE PATIENTS TRIAL LEADS WERE PULLED OUT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21533554 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) TRIAL TO TREAT LOW BACK AND RIGHT LOWER EXTREMITY PAIN. WHEN IN RECOVERY, THE PATIENT BEGAN TO EXPERIENCE NEW ONSET OF LEFT FOOT AND LEFT CALF PAIN. PAIN WAS EXCRUCIATING WHEN TOUCH, ALONG WITH ANY MOVEMENT OF LEFT LOWER EXTREMITY. SYMPTOMS PERSIST DESPITE STIMULATION WAS OFF. THE PHYSICIAN NOTED THAT A NERVE MAY HAVE BECOME IRRITATED WHEN DRIVING THE LEAD. THE LEADS WERE EXPLANTED AND SYMPTOMS RESOLVED. THE FACILITY DISPOSED OF THE EXPLANTED LEADS.

  Patient problems: Pain

  MAUDE report 21105776 ↗
• InjuryDec 5, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENTS TRIAL PROCEDURE WAS ABORTED DUE TO DISCOMFORT AND NOT BEING ABLE TO KEEP THE LEAD POSTERIOR. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE USED LEAD WAS NOT RETURNED.

  Patient problems: Discomfort

  MAUDE report 20851927 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT LOWER EXTREMITY WEAKNESS AND SEVERE PAIN FOLLOWING A TRIAL PROCEDURE. THE PHYSICIAN NOTICED THAT THE PATIENT WAS LEAKING CEREBROSPINAL FLUID AFTER THE LEADS WERE SUCCESSFULLY PLACED. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS GIVEN STEROIDS. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Cerebrospinal Fluid Leakage; Muscle Weakness/Atrophy; Pain

  MAUDE report 20534478 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT A FLUID DISCHARGE AT THE BACK. IT WAS NOTED THAT PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED.

  Patient problems: Fluid Discharge

  MAUDE report 20528514 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NECK PAIN AND HEADACHE. THE PHYSICIAN DETERMINED THAT THE HEADACHE WAS DUE TO CEREBROSPINAL FLUID (CSF) LEAKAGE DURING THE TRIAL PROCEDURE WHEN ADVANCING THE NEEDLE AND THE PATIENT MOVING ON THE TABLE. THE PATIENT WAS ADMINISTERED MEDICATION FOR THE DURAL PUNCTURE. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE, AND THE SYMPTOMS RESOLVED. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Cerebrospinal Fluid Leakage; Dural Tear; Headache; Neck Pain

  MAUDE report 20431229 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVERAL DAYS AFTER A SPINAL CORD STIMULATION TRIAL LEAD IMPLANT PROCEDURE, THE PATIENT FELT NAUSEOUS AND LETHARGIC. THE PATIENT WAS INSTRUCTED TO TURN THE STIMULATION OFF. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL AND TREATED FOR A BRAIN ANEURYSM. THE PHYSICIAN ASSESSED THE EVENT WAS NOT DEVICE-RELATED.

  Patient problems: Aneurysm; Ischemia Stroke; Nausea

  MAUDE report 20286336 ↗
• DeathSep 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE TRIAL LEADS OF THE SPINAL CORD STIMULATOR (SCS), FOR WHICH THE PATIENT WAS UNDER SEDATION, IT WAS NOTED THAT A CEREBROSPINAL FLUID (CSF) LEAK MAY HAVE OCCURRED. ONCE THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TURNED OVER THE PATIENT WAS NOT COHERENT AND NOT RESPONSIVE. THE PATIENT WAS TRANSPORTED TO A HOSPITAL, AND IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY AT THE HOSPITAL. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Cerebrospinal Fluid Leakage; Confusion/ Disorientation

  MAUDE report 20173168 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND NUMBNESS IN THE LEGS FOLLOWING A TRIAL PROCEDURE. THE PATIENT HAD A LARGE AMOUNT OF THICK PUSS AT THE EPIDURAL SPACE PRIOR THE TRIAL. THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS WERE EXPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Numbness; Pain; Unspecified Infection

  MAUDE report 20066897 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF LEG WEAKNESS FOLLOWING A TRIAL PROCEDURE. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LINEAR LEAD PULL. NO DEVICE MALFUNCTION SUSPECTED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20061319 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING THE TRIAL PROCEDURE WHICH THE PHYSICIAN BELIEVED WAS NOT DEVICE RELATED. THE CASE WAS ABORTED AND THE PATIENT WAS REPORTEDLY DOING WELL. THE LEAD WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 19625731 ↗
• InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN AND BURNING SENSATION IN THE LEFT FOOT SINCE THE TRIAL PLACEMENT, AND IT WAS NOT IMPROVED WITH POSITIONING OR CURRENT MEDICATION. THEREFORE, THE PAIN MEDICATION DOSAGE WAS INCREASED, WHICH THE PATIENT IS TOLERATING WELL.

  Patient problems: Burning Sensation; Pain

  MAUDE report 19442178 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR POSSIBLE MENINGITIS AND INFECTION. THE PATIENT HAD A LEAD PULL AND WAS PUT ON A COURSE OF ANTIBIOTICS.

  Patient problems: Bacterial Infection; Fever; Meningitis; Pain; Unspecified Infection

  MAUDE report 19354414 ↗

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-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-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-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.