Avista™ MRI SC-2408-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 441 adverse event reports that list this exact device (DI 08714729904816), received between Jan 3, 2017 and Sep 26, 2026 — classified as 427 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Migration” (194 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 441 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Migration

  Patient problems: Fall

  MAUDE report 50906489 ↗
• InjurySep 25, 2026Nonstandard Device; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906270 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing discomfort at the back while sitting. The patient is very thin, which likely contributed to the discomfort and prominence of the anchors. The patient underwent a procedure wherein the physician adjusted the underlying skin layers to provide additional cushioning over the anchors. The patient was doing well postoperatively.

  Patient problems: Discomfort

  MAUDE report 50899091 ↗
• InjurySep 21, 2026Migration

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50847125 ↗
• InjurySep 17, 2026Migration

  It was reported that the patients spinal cord stimulator lead had migrated due to patient had a fall. Unknown if the fall was device related.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809448 ↗
• InjuryAug 18, 2026Positioning Problem; Migration

  It was reported that the spinal cord stimulation (SCS) patient underwent a lead revision procedure due to significant lead migration requiring repositioning. The physician experienced challenges caused by scar tissue during the placement of the replacement leads; however, the leads were successfully implanted and the procedure was completed. During the same procedure, the physician elected to replace the implantable pulse generator (IPG). Patient postoperative status was not available at the time of reporting. The disposition of the explanted devices was not provided.

  Patient problems: Scar Tissue

  MAUDE report 50311740 ↗
• InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results; Migration

  It was reported that the patient was experiencing pain. Upon interrogation, found one contact with an impedance and leads has also moved down a level which was confirmed with imaging. Program optimization was attempted and was unsuccessful. The patient underwent spinal cord stimulation (SCS) revision procedure. Patient was doing well postoperatively. The hospital kept the explanted products.

  Patient problems: Pain

  MAUDE report 50290571 ↗
• MalfunctionJul 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bone Fracture(s)

  MAUDE report 25893618 ↗
• InjuryJun 19, 2026High impedance; Unexpected Therapeutic Results; Charging Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION AND HAD A STIMULATION IN THE ABDOMINAL REGION DUE TO A CONFIRMED LEAD MIGRATION VIA X-RAY AND THE LEADS HAD HIGH IMPEDANCE.

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 25568246 ↗
• InjuryJun 17, 2026Unexpected Therapeutic Results; Low impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT SOMETIMES EXPERIENCED INADEQUATE STIMULATION OR NO STIMULATION AT ALL. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT HAS FULLY RECOVERED AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Fall; Inadequate Pain Relief; Pain

  MAUDE report 25538390 ↗
• MalfunctionJun 5, 2026Fracture

  IT WAS REPORTED THAT THE DURING AN IMPLANT PROCEDURE, THE LEAD TAIL BROKE IN HALF WHEN THE PHYSICIAN WAS MOVING THE LEAD INTO THE MIDLINE INCISION. THE CAUSE WAS UNKNOWN AND NOTHING UNUSUAL DURING THE PROCEDURE. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417131 ↗
• InjuryMay 18, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210936 ↗
• InjuryApr 11, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 24848175 ↗
• InjuryMar 26, 2026High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEADS AND LEAD MIGRATION WHICH WAS CONFIRMED THROUGH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24696118 ↗
• InjuryMar 13, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF FROM THEIR SPINAL CORD STIMULATION (SCS) LEADS. THE PHYSICIAN WAS NOT CERTAIN IF THE LEAD POSITION CHANGED BUT NOTED THAT THE LEADS WERE PLACED MORE CEPHALAD THAN USUAL. THE PHYSICIAN ALSO MENTIONED THAT THE LEAD POSITION COULD HAVE BEEN A FACTOR IN THE REDUCED PAIN RELIEF EFFECT. THE PATIENT REQUESTED THE LEADS BE UPGRADED. THEREFORE THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24596152 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE LEAD SITE AND WAS ADMINISTERED WITH ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection

  MAUDE report 24593117 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE SPINAL CORD STIMULATOR (SCS) LEADS SITE DUE TO IMPAIRED WOUND HEALING. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS AND IPG WERE EXPLANTED AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Bacterial Infection; Impaired Healing

  MAUDE report 24440336 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION IN A NON-TARGET AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE SPINAL CORD STIMULATION (SCS) LEAD AND CLIK ANCHOR WERE REPLACED. DURING THE PROCEDURE WHEN THE PHYSICIAN EXPOSED THE CLIK ANCHOR, THE SCREW WAS LOOSE INSIDE THE WHITE PLASTIC OF THE ANCHOR, AS IF IT HAD UNSCREWED ITSELF. THE PHYSICIAN DOES NOT KNOW WHY THE CLIK ANCHOR WAS NOT SECURED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT HAS FULLY RECOVERED. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

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

  MAUDE report 24415315 ↗
• InjuryFeb 23, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENTS PAIN WAS NO LONGER COVERED BY THE SPINAL CORD STIMULATION (SCS) LEAD. IMAGING CONFIRMED THAT THE LEAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD WAS REPOSITIONED. NO DEVICES WERE IMPLANTED OR EXPLANTED. THE PATIENT WAS DOING FINE POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24415301 ↗
• InjuryFeb 20, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEAD OF THE PATIENT HAD AN IMPEDANCE. THE PATIENT UNDERWENT AND SCS LEAD REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401289 ↗
• InjuryFeb 19, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD DEMONSTRATED PERSISTENTLY HIGH IMPEDANCES SINCE THE TIME OF IMPLANTATION. THE LEAD WAS LEFT IN SITU BECAUSE REPLACEMENT WAS CONSIDERED TECHNICALLY CHALLENGING DUE TO THE PATIENTS EXTREME OBESITY. THE PATIENT SUBSEQUENTLY REQUIRED MAGNETIC RESONANCE IMAGING (MRI), AND THEREFORE, UNDERWENT AN EXPLANT PROCEDURE TO ALLOW THE MRI TO BE PERFORMED. THE PATIENT RECOVERED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391919 ↗
• InjuryFeb 18, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24379742 ↗
• InjuryFeb 12, 2026Migration

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE. WOUND DEHISCENCE AT THE MIDLINE INCISION WAS NOTED. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. DURING THE PROCEDURE, IT WAS ALSO FOUND OUT THAT THE LEADS HAD MIGRATED.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 24323247 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEAD WAS EXPOSED FOLLOWING THE REMOVAL OF A GROWTH AND SCAB IN THE CERVICAL INCISION SITE. (MFR. REPORT NO.3006630150-2026-00776) IT WAS NOTED THAT DUE TO PATIENTS SMOKING HABITS, THE INCISION DID NOT PROPERLY HEAL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Impaired Healing

  MAUDE report 24297158 ↗
• InjuryFeb 9, 2026Migration

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD. THE EXPLANTED LEADS WERE KEPT BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290767 ↗

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-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-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-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-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-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.