Artisan™ SC-8216-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 08714729779902), received between Dec 5, 2016 and Sep 30, 2026 — classified as 395 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (144 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 451 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a patient advocate that the patient was experiencing a medical emergency and was admitted to the hospital for stroke evaluation. The patient was incoherent and recently fell but not on the spinal cords stimulation (SCS) implant. The patient hasn't used the stimulator in sometime but could not recall approximated time and reason. However, the patient was in need of an urgent MRI.

  Patient problems: Fall; Stroke/CVA

  MAUDE report 50942054 ↗
• InjurySep 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892212 ↗
• InjurySep 24, 2026Migration

  It was reported that the Spinal Cord Stimulator (SCS) paddle lead of the patient came out of the epidural space. The patient underwent a SCS paddle lead revision procedure. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888540 ↗
• InjurySep 23, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875618 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient had a stroke, broke the hip and it was decided to explant the system for unknown reasons. No further information has been obtained.

  Patient problems: Stroke/CVA; Unspecified Tissue Injury

  MAUDE report 50793073 ↗
• InjuryAug 28, 2026Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration

  It was reported that the paddle had shifted position. During the paddle adjustment procedure, a contact became loose. As a result, the entire paddle assembly was replaced. The old paddle remains at the facility per facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50506248 ↗
• InjuryAug 28, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient experienced inadequate pain relief. The patient felt a pop and per physician the paddle Spinal Cord Stimulation (SCS) lead had migrated as confirmed via imaging. The patient underwent Spinal Cord Stimulator (SCS) explant procedure and was doing well postoperatively. All explanted device components were not released by the facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50501360 ↗
• InjuryAug 7, 2026Migration

  It was reported that the patients Spinal Cord Stimulator (SCS) paddle lead had migrated, and this was confirmed through imaging. As a result, the patient underwent an SCS paddle lead replacement procedure and was doing well postoperatively. The explanted device was not able to be returned due to hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183838 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO NUMBNESS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Numbness

  MAUDE report 25893757 ↗
• InjuryJul 15, 2026Unexpected Therapeutic Results

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD SEVERAL EPISODES OF SEMI-PARALYSIS, SPOTS ON HER BRAIN, AND RECENT MEMORY LOSS. THE PATIENT HAS NOT USED THE SPINAL CORD STIMULATION (SCS) FOR OVER A YEAR DUE TO INADEQUATE STIMULATION, HOWEVER, IMAGING WILL BE TAKEN.

  Patient problems: Memory Loss/Impairment; Paralysis

  MAUDE report 25833735 ↗
• InjuryJun 23, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION, WHICH WAS CONFIRMED THROUGH IMAGING. AS A RESULT, THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WAS REPOSITIONED. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN USE.

  Patient problems: Pain

  MAUDE report 25600505 ↗
• InjuryMay 29, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT WAS EXPERIENCING SHOCK AND PAIN.

  Patient problems: Implant Pain; Pain; Shock

  MAUDE report 25336417 ↗
• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEADS WERE FRACTURED DUE TO PATIENT FELL SEVERAL TIMES. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

  Patient problems: Fall

  MAUDE report 25156599 ↗
• InjuryMay 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO IMPROPER LEAD PLACEMENT. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133507 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an implant procedure to cover pain areas and it was noted in the neuromonitoring that the patient lost signal in the bilateral legs. Eventually, the patient regained motor senses back to normal and the procedure was completed without other complications. The patient was doing well postoperatively.Additional information was received that the patient's symptoms were not device related.

  Patient problems: Numbness

  MAUDE report 25122306 ↗
• InjuryMay 5, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084695 ↗
• InjuryMay 5, 2026High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES AND THE PATIENT WAS EXPERIENCING PAIN AT THE BATTERY SITE. THE PATIENT UNDERWENT A LEAD AND GENERATOR REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084095 ↗
• InjuryApr 17, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT NEEDED A BETTER RIGHT-SIDE STIMULATION COVERAGE. THE PHYSICIAN ADDED A LINEAR LEAD TO THE RIGHT SIDE OF THE PADDLE LEAD TO ENHANCE RIGHT SIDE COVERAGE AND REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG) TO ACCOMMODATE THE ADDED LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS NOT RELEASED BY THE MEDICAL FACILITY TO BE RETURNED.

  Patient problems: Pain

  MAUDE report 24913678 ↗
• InjuryApr 9, 2026Migration

  IT WAS REPORTED THAT THE LEAD MIGRATED. THE PATIENT UNDERWENT A PADDLE REPOSITIONING PROCEDURE. PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834947 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS ABORTED THE SPINAL CORD STIMULATOR DUE TO NEURO-MONITORING REPORTED LOSS OF MOTORS DURING THE PROCEDURE. THE PHYSICIAN ABORTED IN ABONDANCE OF CAUTION BUT DID NOT UNDERSTAND HOW WHAT HE WAS DOING WITH THE PADDLE COULD HAVE CAUSED WHAT THE MONITORING COMPANY WAS SHOWING. THE DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 24721822 ↗
• InjuryMar 20, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 24647015 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVING TOO MUCH PRESSURE IN HIS SPINE WITH A PADDLE LEAD. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE. PATIENT DID WELL POSTOPERATIVELY. NO DEVICE TO RETURN, ARTISAN LEAD WAS DISCARDED.

  Patient problems: Discomfort

  MAUDE report 24646196 ↗
• MalfunctionMar 9, 2026Fracture; High impedance; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) PADDLE LEAD WAS FRAYED AROUND CONTACT 5. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED DUE TO FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547060 ↗
• InjuryFeb 27, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD WAS REPOSITIONED DUE TO MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24475237 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445499 ↗

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-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-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-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-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-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
• 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.