NA SC-4254Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729762751), received between May 24, 2017 and Sep 15, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

21 other recalls cover devices cleared under the same FDA submission (P030017, P150031); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Use of Device Problem; Migration

  It was reported that the deep brain stimulation (DBS) patient underwent an implant procedure during which the physician assessed the tunneling tool was too sharp and not rigid enough to bend properly. A non-Boston Scientific (BSC) tunneling tool was used to complete the procedure. Post-operative computerized tomography (CT) imaging that was taken confirmed the left lead had migrated which the physician attributed to the BSC tunneling tool difficulty. Therefore, the patient underwent a revision procedure the following day to replace the left lead. The tunneling tool and explanted lead will not be returned as they were discarded by the medical facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776037 ↗
• MalfunctionMay 5, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) TUNNELING TOOL WAS INTENDED TO BE USED IN AN IMPLANTATION PROCEDURE. UPON OPENING THE PRODUCT IN QUESTION AND ASSEMBLING THE HANDLE AND SHAFT, A VINYL-LIKE MATERIAL WAS OBSERVED WRAPPED AROUND THE SHAFT. CONSEQUENTLY, THIS UNIT WAS NOT UTILIZED, AND INSTEAD, ANOTHER UNIT OF THE SAME MODEL WAS EMPLOYED. GIVEN THAT THE FOREIGN MATERIAL WAS WRAPPED AROUND THE SHAFT, IT IS CONSIDERED UNLIKELY THAT IT BECAME ATTACHED DURING THE UNPACKING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084710 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, PATIENTS VESSEL WAS NICKED WHILE USING A BOSTON SCIENTIFIC TUNNELER AND EXPERIENCED BLEEDING. THE PHYSICIAN APPLIED PRESSURE TO STOP THE BLEEDING AND THE ISSUE WAS RESOLVED. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Nerve Damage

  MAUDE report 21267226 ↗
• InjuryOct 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY WHILE TUNNELING TO IMPLANT A DEEP BRAIN STIMULATION LEAD. THE PHYSICIAN BELIEVED THE TUNNELING TOOL WAS TOO FLEXIBLE, WHICH LED TO HEMORRHAGING AND BLOOD LOSS IN THE PATIENT DURING THE SURGERY. A NON-BOSTON SCIENTIFIC TUNNELING TOOL WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS HOSPITALIZED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION RECEIVED THAT ADAPTIVE ANESTHESIA, AND COMPRESSES WERE DONE IN RESPONSE TO THE HEMORRHAGING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20488281 ↗
• InjuryDec 21, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATOR IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY USING THE TUNNELING TOOL AS THE DEVICE DID NOT GIVE ENOUGH SUPPORT. THE PHYSICIAN CHANGED THE PATIENTS NECK POSITION, USED A DIFFERENT TYPE OF TUNNELING TOOL AND MADE AN ADDITIONAL WOUND TO INSERT THE LEAD AND COMPLETE THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Injury

  MAUDE report 11047798 ↗
• InjuryDec 18, 2020Use of Device Problem; Structural Problem; Use of Device Problem; Structural Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATOR IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY USING THE TUNNELING TOOLS WHEN TRYING TO IMPLANT THE LEAD EXTENSION. THE PHYSICIAN USED TWO DIFFERENT TUNNELING TOOLS WHICH BOTH BENT AND DAMAGED THE SILICONE ON THE TOOLS. THE PHYSICIAN THEN HAD TO MAKE AN ADDITIONAL INCISION IN THE MIDDLE OF THE PATIENTS NECK TO PASS THE TUNNELING TOOL TO THE CHEST IN WHICH THE LEAD EXTENSION WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Injury

  MAUDE report 11038606 ↗
• InjuryMay 24, 2017Device Expiration Issue; Device Expiration Issue

  A REPORT WAS RECEIVED THAT DURING A PERMANENT IPG IMPLANTATION PROCEDURE, AN EXPIRED TUNNELING TOOL WAS USED. THE TUNNELING TOOL WAS FIVE DAYS BEYOND THE EXPIRATION DATE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6589298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017, P150031. 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-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• 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-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• 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-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-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-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the
• 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-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-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

…and 6 more.