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

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729820741), received between Dec 26, 2016 and Dec 11, 2025 — classified as 1 death, 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (3 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT DUE TO CONCERNS ABOUT LEFT JAW PULLING TO THE SIDE. IT WAS UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE TRIAL LEADS WERE PULLED OUT AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 23775906 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY DEPARTMENT TO HAVE THE TRIAL LEADS PULLED OUT DUE TO DRAINAGE AT THE LEAD SITE.

  Patient problems: Fluid Discharge

  MAUDE report 23358463 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PROCEDURAL PAIN FOLLOWING THE SPINAL CORD STIMULATOR (SCS) TRIAL IMPLANT PROCEDURE. THE PATIENT UNDERWENT AN SCS TRIAL LEADS REMOVAL PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WILL BE DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 23009717 ↗
• InjuryMay 20, 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) TRIAL PATIENT WAS TAKEN TO THE EMERGENCY ROOM DUE TO A POSSIBLE STROKE AND THROMBOSIS. THE PATIENT EXPERIENCED SLURRED SPEECH AND IMMOBILITY OF THE RIGHT ARM. THE PHYSICIAN ASSESSED THAT THE DEVICE NOR THE PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENTS COMPLICATIONS AS THE PATIENT HAD SUSPENDED THEIR PRE-EXISTING ANTICOAGULANT MEDICATION FOR A PROLONGED PERIOD OF TIME PRIOR TO THE TRIAL PROCEDURE. THE PATIENTS TRIAL LEADS WERE REMOVED THE DAY AFTER THE PATIENTS SYMPTOMS BEGAN AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONALLY, THE PATIENT WAS PLACED BACK ON THEIR ANTICOAGULANT MEDICATION ONCE AGAIN AND HAS SINCE RECOVERED. THE REMOVED TRIAL LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Ischemia Stroke; Paralysis; Speech Disorder; Thrombosis/Thrombus

  MAUDE report 22057473 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE LEADS OF THE PATIENT HAD FRACTURED DUE TO MULTIPLE ACCIDENTS THAT THE PATIENT HAD EXPERIENCED. AN X-RAY IMAGING CONFIRMED THE LEAD FRACTURED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667125 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA SOCIAL MEDIA THAT THE PATIENT HAD A LEAD PULL DUE TO PAIN. TH EXPLANTED DEVICES WILL NOT BE RETURNED, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 18989058 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INCREASING PAIN AND INCREASING NUMBNESS FROM THE TORSO AND BELOW, FOLLOWING A TRIAL PROCEDURE. THE LEADS WERE PULLED IMMEDIATELY AND DISCOVERED BLEEDING AT THE EPIDURAL BY IMAGING. THE PATIENT WAS TRANSFERRED TO A LOCAL TRAUMA FACILITY FOR EMERGENT DECOMPRESSION SURGERY. THE LEADS WILL NOT BE RETURNED PER FACILITY PROTOCOL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Numbness; Pain

  MAUDE report 18989048 ↗
• InjuryOct 19, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE CHEST AND MUSCLE SPASM AFTER THE TRIAL LEAD WAS PLACED. X-RAY WAS TAKEN AND REVEALED LEAD MIGRATION. THE LEADS WERE PULLED AND DISCARDED BY THE MEDICAL FACILITY.

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

  MAUDE report 17963103 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF PROCEDURAL SORENESS. THE PATIENT HAD AN EARLY LEAD PULL AND LEADS WILL NOT BE RETURNED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 17223315 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT BECAME SICK TO HER STOMACH A DAY AFTER THE TRIAL IMPLANT PROCEDURE AND IN THE MORNING WHEN SHE WOKE UP, SHE WAS UNABLE TO SPEAK NORMALLY. THE PATIENT EXPERIENCED A SEIZURE AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE PHYSICIAN DOES NOT BELIEVE THAT THE SEIZURE WAS DEVICE RELATED. THE TRIAL LEADS WERE EXPLANTED TO PERFORM IMAGING AND BLOODWORK. THE PATIENT WAS DOING FINE POST-OPERATIVELY AND HAS NOT EXPERIENCED ANY FURTHER SEIZURES. THE EXPLANTED TRIAL LEADS WERE NOT RETURNED PER MEDICAL FACILITY POLICY.

  Patient problems: Convulsion/Seizure; Speech Disorder

  MAUDE report 16878584 ↗
• MalfunctionOct 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LEAD WAS FRAYING DURING A TRIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655611 ↗
• InjuryJul 26, 2021Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE TRIAL LEADS WERE PULLED OUT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12225334 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS TRIAL WAS ABORTED DUE TO EXCESSIVE BLEEDING AT THE INSERTION SITE. THE PHYSICIAN REMOVED THE TRIAL LEADS AND THE LEADS WERE NOT RETURNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11755944 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A NEW PAIN IN THE HEAD DURING A TRIAL PERIOD. THE PATIENT HAD AN EARLY LEAD PULL AND WAS HOSPITALIZED. EXPLANTED LEADS WERE DISCARDED.

  Patient problems: Pain

  MAUDE report 11388296 ↗
• InjuryOct 22, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASED NECK PAIN WITH HEADACHES. THE LEADS ALSO SHOWED LOW IMPEDANCES. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS DOING WELL. EXPLANTED LEADS WILL NOT BE RETURNED.

  Patient problems: Headache; Neck Pain; No Code Available

  MAUDE report 10717626 ↗
• DeathMay 19, 2020Adverse 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 THE PATIENT PASSED AWAY. IT IS INDICATED THAT A WRONGFUL DEATH LAWSUIT HAS BEEN FILED AGAINST THE PHYSICIAN AND THE FACILITY. NO ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE. THE DATE OF DEATH IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED TO THE MANUFACTURER.

  Patient problems: Death

  MAUDE report 10073317 ↗
• InjuryJun 5, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION. SYMPTOMS OF FEVER, HEADACHE, REDNESS, AND DRAINAGE AT THE INCISION SITE WERE NOTED. IT WAS UNKNOWN WHAT CAUSED THE INFECTION. THE PATIENT WAS PRESCRIBED WITH CIPRO AND BACTRIM. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE.

  Patient problems: Bacterial Infection; Fever; Fluid Discharge; Headache; No Code Available

  MAUDE report 8672761 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO SEVERE PAIN IN THE UPPER BACK, ARMS AND SHOULDER. THE PATIENT WAS UNABLE TO MOVE THE LEGS AND SUBDURAL HEMATOMA WAS NOTED. THE PHYSICIAN OPTED TO REMOVE THE TRIAL LEADS AS THE PATIENT WAS STILL HAVING PAIN AFTER AN HOUR OF NO STIMULATION. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO RESOLVE THE HEMATOMA AND THE PHYSICIAN CONFIRMED THAT SOME OF THE PATIENTS MOVEMENTS HAD RETURNED.

  Patient problems: Hematoma; No Code Available; Pain; Weakness

  MAUDE report 8648235 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS GETTING LIGHT HEADED. THE PHYSICIAN BELIEVED THAT THE LEAD WAS CAUSING PRESSURE WHICH CAUSED A DECREASED ABILITY FOR BLOOD FLOW. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Dizziness

  MAUDE report 8582664 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT DURING A LEAD PULL A POSSIBILITY OF CEREBROSPINAL FLUID LEAKAGE WAS NOTED. THE PATIENT WAS TREATED WITH BLOOD PATCH AND WAS STILL EXPERIENCING SEVERE HEADACHE AND CEREBROSPINAL FLUID LEAKAGE. THE PATIENT WAS BEING WORKED UP FOR POSSIBLE INFECTION. THE PHYSICIAN SUSPECTED THAT LEAD WAS INTRATHECAL DURING TRIAL.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Unspecified Infection

  MAUDE report 8091766 ↗
• InjuryAug 28, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING STOMACH ISSUES AND IT WAS DISCOVERED THAT THE PATIENT WAS HAVING ANXIETY ISSUES THAT COULD BE AFFECTING THE STOMACH. IT WAS ALSO REPORTED THAT THE PATIENT HAD SORENESS IN AN UNKNOWN AREA AND HAD LOST COVERAGE IN THE LEFT ARM AND WRIST. THE PATIENT WAS PRESCRIBED ANXIETY MEDICATION AND UNDERWENT A LEAD PULL PROCEDURE.

  Patient problems: Anxiety; Discomfort; Undesired Nerve Stimulation

  MAUDE report 7824720 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A TRIAL PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PATIENT UNDERWENT AN EARLY LEAD PULL.

  Patient problems: Pain

  MAUDE report 7558044 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD AN EARLY LEAD PULL DUE TO PAIN AT THE LEAD SITE.

  Patient problems: Pain

  MAUDE report 6970664 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT WHILE ON TRIAL THE PATIENT EXPERIENCED ALLERGIC REACTIONS. SYMPTOMS WERE ITCHING AND FEVER. THE PATIENT UNDERWENT A LEAD PULL AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Fever; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 6948019 ↗
• InjuryMay 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED SUPERFICIAL INFECTION AT THE LEAD SITE AFTER THE TRIAL LEADS WERE PULLED OUT. THE PATIENT HAD FEVER AND THE INFECTION WAS RELATED TO SUPERFICIAL NEEDLE ENTRY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POSSIBLE EPIDURAL ABSCESS AND WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS DOING WELL.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 6602868 ↗

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-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-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-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-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-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.