NA SC-4252Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729784456), received between Oct 29, 2020 and Apr 28, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THIS TUNNELING TOOL PACKAGING WAS OPENED IN PREPARATION FOR USE AND A HAIR WAS NOTED TO BE PRESENT WITHIN THE STERILE PACKAGING. THE TUNNELING TOOL WAS NOT USED. THE TOOL AND PACKAGING WERE DISCARDED AND WERE NOT RETURNED FOR PHYSICAL ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017714 ↗
• InjuryNov 24, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE THE TUNNELING TOOL WAS NOT SHARP ENOUGH ON THE TOP. THE PATIENT WAS EXPERIENCING DISCOMFORT AND PAIN DUE TO THE SURGEONS EXTRA EFFORT DURING THE TUNNELING, AND AN EXTRA SUTURE WAS REQUIRED. THE PHYSICIAN FEELS THAT THE PATIENT HAD AN INCREASED RISK OF INFECTION DUE TO ADDING THE EXTRA SUTURE. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 10891418 ↗
• InjuryOct 29, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT THE USE OF A SCALPEL WAS REQUIRED TO MAKE AN ADDITIONAL INCISION DURING THE IMPLANT PROCEDURE BECAUSE THE TUNNELING TOOL WAS NOT SHARP ENOUGH. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE FOLLOWING THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT NO INTERVENTION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10759001 ↗

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-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• 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-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-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-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-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-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-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.