Linear™ 3-4 SC-2352-50ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729789703), received between Jan 26, 2017 and Jul 22, 2025 — classified as 1 death, 8 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE AND UPON INJECTING THE LIDOCAINE THE PATIENT VOMITED WATER ON THE FLOOR. THE PATIENT WAS ROLLED BACK ONTO THE STRETCHER AND WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS DOING WELL.

  Patient problems: Vomiting

  MAUDE report 22570853 ↗
• DeathSep 19, 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 PASSED AWAY FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS DEATH WAS NOT DEVICE OR PROCEDURE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775728 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STAPHYLOCOCCUS INFECTION DURING THE TRIAL PROCEDURE. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE.

  Patient problems: Staphylococcus Aureus

  MAUDE report 10576437 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE DURING HIS IMPLANT TRIAL AND WAS HOSPITALIZED. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Code Available; Stroke/CVA

  MAUDE report 10193027 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT IMMEDIATELY FOLLOWING A TRIAL PROCEDURE, THE PATIENT HAD EPILEPSY AND WAS HAVING A SEIZURE. THE PATIENT WAS TRANSPORTED TO A HOSPITAL AND WAS PLACED IN NEURO INTENSIVE CARE UNIT (ICU) AS THEY WERE UNABLE TO GET THE SEIZURES UNDER CONTROL. THE PHYSICIAN BELIEVED THAT THE SEIZURE WAS NOT RELATED TO THE DEVICE OR PROCEDURE. IT WAS NOTED THAT THE PATIENT WAS A KNOWN EPILEPTIC AND HAD HISTORY OF SEIZURES. THE PHYSICIAN REMOVED THE LEADS WHILE THE PATIENT WAS IN THE HOSPITAL.

  Patient problems: Seizures

  MAUDE report 7500650 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE DURING THE TRIAL PROCEDURE THE PATIENT SUFFERED A STROKE AND WAS IN THE INTENSIVE CARE UNIT. THE PHYSICIAN DID NOT BELIEVE IT WAS DUE TO THE DEVICE. THE PATIENT WILL UNDERGO A LEAD PULL. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 7447027 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT FOLLOWING THE TRIAL PROCEDURE THE PATIENT HAD DEVELOPED HEMATOMA AND IT WAS UNKNOWN ON WHAT CAUSED IT. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENTS TRIAL LEAD WERE THEN EXPLANTED ON THE SAME DATE.

  Patient problems: Hematoma

  MAUDE report 7144595 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED PAIN ABOVE AND AROUND THE LEADS ENTRY SITE AFTER THE TRIAL PROCEDURE. THE LEADS WERE EXPLANTED EARLIER THAN PLANNED AND THE EVENT HAS RESOLVED. THE PHYSICIAN ASSESSED THAT THE PAIN WAS DEVICE, PROCEDURE AND STIMULATION RELATED.

  Patient problems: Pain

  MAUDE report 6574168 ↗
• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT PATIENT DEVELOPED A SEVERE HEADACHE ONE DAY AFTER THE TRIAL PROCEDURE. THE PHYSICIAN SUSPECTED THE HEADACHE WAS DUE TO A DURAL PUNCTURE CAUSED DURING THE INSERTION OF THE TUOHEY NEEDLE. THE PATIENT WAS TREATED WITH IV FLUIDS, ANALGESIA, A BLOOD PATCH AND BED REST. THE PATIENT WAS STABLE AND RELEASED FROM THE HOSPITAL.

  Patient problems: Headache; Needle Stick/Puncture

  MAUDE report 6341602 ↗
• InjuryJan 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE TRIAL PATIENT HAD A PERIPHERAL SUBCUTANEOUS LEAD THAT WAS BURNING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: Discomfort

  MAUDE report 6281825 ↗

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-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-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-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.