Artisan™ SC-8216-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 424 adverse event reports that list this exact device (DI 08714729779919), received between Dec 12, 2016 and Sep 24, 2026 — classified as 378 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (146 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 424 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient was only feeling stimulation when tilting neck to the right and strong jolts when moving the arms. It was also stated that the patient's spinal cord stimulator (SCS) paddle leads had high impedance. The patient underwent a procedure wherein the IPG and paddle leads were replaced.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50878646 ↗
• InjurySep 15, 2026High impedance

  It was reported that the lead had high impedances. The patient underwent lead replacement procedure. The patient was stable postoperatively. The explanted leads was disposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774128 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient was intubated at the hospital and needed an MRI scan to rule out stroke. The patient was then transferred to the hospice unit. There was no suspected adverse event related to the stimulation.

  Patient problems: Stroke/CVA

  MAUDE report 50419146 ↗
• InjuryAug 4, 2026High impedance

  It was reported that the patients lead had high impedances. The patient underwent a lead and Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device components were not returned by the medical facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136112 ↗
• InjuryJul 31, 2026Migration

  It was reported that the Spinal Cord Stimulator (SCS) paddle lead of the patient was pulled out of the space. The device migration was confirmed thru x-ray imaging. The patient underwent a SCS paddle lead repositioning procedure. The device remained implanted and in service. No further information has been obtained.Additional information was received that the patient doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101567 ↗
• InjuryJul 21, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS PADDLE LEAD REVISION, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISPOSED OF BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892736 ↗
• InjuryJul 12, 2026High impedance; Charging Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED DIFFICULTY IN CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE SPINAL CORD STIMULATOR (SCS) LEAD HAD SOME IMPEDANCES. IT WAS ALSO MENTIONED THAT THE PATIENT NEEDED A MAGNETIC RESONANCE IMAGING (MRI) AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND SCS LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791414 ↗
• InjuryJul 9, 2026Off-Label Use; Migration

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN, SWELLING AND HOT TO TOUCH IN THE CERVICAL AREA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS PROVIDED WITH INTRAVENOUS (IV) ANTIBIOTICS. IT WAS ALSO NOTED THAT THE PATIENT HAD SEROMA AND WAS DRAINED. IMAGING RESULTS SHOWED THAT SPINAL CORD STIMULATOR (SCS) PADDLE HAD MIGRATED. THE PATIENT WAS DOING WELL AND NO FURTHER ACTION WAS NEEDED. THE DEVICES REMAINED IMPLANTED AND IN SERVICE.

  Patient problems: Erythema; Inflammation; Pain; Seroma; Swelling/ Edema

  MAUDE report 25767195 ↗
• InjuryJul 1, 2026Migration

  It was reported that the patient's right spinal cord stimulator (SCS) paddle lead had migrated. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted lead was discarded by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680090 ↗
• InjuryJun 16, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REVISION DUE TO HIGH IMPEDANCES AND IMPLANTABLE PULSE GENERATION (IPG) DUE TO COGNITIVE DEFICITS. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED PRODUCTS WERE NOT RELEASED BY THE FACILITY.

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

  MAUDE report 25524938 ↗
• InjuryJun 12, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO PADDLE LEAD MIGRATION. THE PHYSICIAN WAS UNABLE TO REPOSITION THE PADDLE LEAD DUE TO SCAR TISSUE AND DECIDED TO REMOVE THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain; Scar Tissue

  MAUDE report 25484184 ↗
• MalfunctionJun 4, 2026Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATOR (SCS) HAD POTENTIAL DEFECT AND DISLODGED CONTACT. THE PATIENT UNDERWENT REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392666 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218734 ↗
• InjuryApr 28, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD MIGRATED WHICH CAUSED THE PATIENT TO EXPERIENCE LOSS OF STIMULATION. X-RAY IMAGING CONFIRMED THE DEVICE MIGRATION. THE PATIENT UNDERWENT A SCS LEAD REVISION. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Pain

  MAUDE report 25017814 ↗
• InjuryApr 7, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT REPOSITIONING PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807986 ↗
• InjuryMar 30, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709062 ↗
• InjuryMar 4, 2026High impedance; Migration

  IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED CAUSING HIGH IMPEDANCE. IMAGING WAS TAKEN AND SPINAL CORD STIMULATION (SCS) LEAD MIGRATION WAS CONFIRMED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PADDLE LEAD WAS REPLACED. THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Fall

  MAUDE report 24505897 ↗
• InjuryFeb 18, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) PADDLE LEAD SHOWED A LOT OF HIGH IMPEDANCE RATINGS UPON DEVICE OPTIMIZATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375135 ↗
• InjuryFeb 17, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A NERVE DAMAGE FOLLOWING AN IMPLANT PROCEDURE. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND SEVERE PAIN, ELECTRIC SHOCKING SENSATIONS, AND SPASMS ACROSS THE BACK OF THE WAIST BAND AREA DESPITE PROGRAM OPTIMIZATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPLANTED.

  Patient problems: Inappropriate Device Stimulation of Tissue; Nerve Damage; Pain; Undesired Nerve Stimulation

  MAUDE report 24365271 ↗
• InjuryFeb 4, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCES THAT WAS CAUSING UNNECESSARY STIMULATION IN THE RIBS AND STOMACH, AND THE PATIENT WAS ALSO EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 24255562 ↗
• InjuryJan 26, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE LEAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE LEAD REMAIN IMPLANTED AND IN USE.

  Patient problems: Pain

  MAUDE report 24176632 ↗
• InjuryJan 14, 2026High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT LEAD AN EXPLANT PROCEDURE AND IS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075971 ↗
• InjuryDec 31, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WAS CUT DURING A NON-CONFIRMED DEVICE RELATED PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PADDLE LEAD WAS REPLACED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933092 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868087 ↗
• InjuryDec 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED SPINAL CORD STIMULATOR (SCS) LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815887 ↗

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-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-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-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.