Infinion™ 16 SC-2316-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 343 adverse event reports that list this exact device (DI 08714729797814), received between Dec 2, 2016 and Sep 25, 2026 — classified as 246 injuries, 97 malfunctions.

The most frequently reported specific device problem is “High impedance” (246 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 343 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904254 ↗
• InjuryJul 22, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT LEAD EXHIBITED HIGH IMPEDANCES. A LEAD REPLACEMENT PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING THE NEW LEADS IN AN ADEQUATE LOCATION DUE TO THE PATIENT ANATOMY. AS A RESULT, THE REVISION PROCEDURE WAS ABORTED. ALL IMPLANTED DEVICE COMPONENTS WERE EXPLANTED AND RETAINED BY THE MEDICAL FACILITY. NO ADDITIONAL PATIENT COMPLICATIONS OR OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25902074 ↗
• InjuryMay 25, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  THE LEAD WAS REPORTED TO HAVE MIGRATED AND EXHIBITED HIGH IMPEDANCE LEVELS. THE PATIENT EXPERIENCED UNWANTED STIMULATION, INCLUDING BURNING SENSATIONS AND PAIN LOCALIZED AT THE BATTERY SITE. PROGRAMMING OPTIMIZATION WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. PATIENT WAS WORKING WITH THE OFFICE TO GET APPROVAL WITH INSURANCE FOR A REVISION.

  Patient problems: Burning Sensation; Pain

  MAUDE report 25272480 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A SPINAL CORD STIMULATION (SCS) DEVICE UNDERWENT A REVISION PROCEDURE FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650591 ↗
• InjuryMar 19, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED DUE TO IMPEDANCES. NO SYMPTOMS OR STIMULATION ISSUES WERE EXPERIENCED AS A RESULT OF THIS FINDING. THE LEAD WAS DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT MADE A NORMAL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641273 ↗
• InjuryFeb 20, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SPINAL CORD STIMULATION (SCS) LEADS WERE RELOCATED. THE PATIENT WAS NOTED TO HAVE RECOVERED POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 24407871 ↗
• InjuryFeb 9, 2026High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES WHICH LED TO INADEQUATE STIMULATION AS THE IMPEDED CONTACTS WERE NEEDED TO GET COVERAGE OF HER PAIN. IT WAS ASSESSED THAT THE HIGH IMPEDANCE CONTACTS MAY HAVE POSSIBLY CAUSED THE PAIN AT THE IPG SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG AND LEADS WERE REMOVED AND REPLACED. THE IPG SITE WAS CHANGED FROM LEFT GLUTEAL TO LEFT FLANK. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE HOSPITAL.

  Patient problems: Hematoma; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 24300677 ↗
• InjuryJan 14, 2026Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED AND FRACTURED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24073073 ↗
• InjuryDec 23, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REVISED 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 23885151 ↗
• MalfunctionDec 12, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. IT WAS MENTIONED THAT THE LEADS ARE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794770 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230043 ↗
• InjurySep 3, 2025High impedance; Charging Problem; High impedance; Charging Problem

  IT WAS REPORTED THAT PATIENTS LEADS HAD HIGH IMPEDANCES AND UNDERWENT A REPLACEMENT PROCEDURE. PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED. ADDITIONAL INFORMATION OBTAINED THAT THE PATIENT HAD INCREASED CHARGING BURDEN DUE TO THE HIGH IMPEDANCES. THE IMPLANTABLE PULSE GENERATOR (IPG) HAS BEEN REPLACED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952084 ↗
• InjuryJun 26, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM, HOWEVER IT IS UNCLEAR IF THE IMPEDANCES WERE FROM THE LEADS OR THE LEAD SPLITTERS. REPROGRAMMING WAS PERFORMED BUT DID NOT RESOLVE THE INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH ALL THE DEVICES WERE EXPLANTED AND REPLACED. THE PATIENT IS DOING WELL POST OPERATIVELY, AND THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 22334055 ↗
• InjuryJun 25, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSUFFICIENT THERAPY FROM THE SPINAL CORD STIMULATION SYSTEM. IT WAS NOTED THAT THE LEADS DISPLAYED HIGH IMPEDANCE READINGS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS AND LEAD SPLITTERS WERE EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AS PER THE HOSPITALS INFECTION CONTROL POLICY.

  Patient problems: Pain

  MAUDE report 22333572 ↗
• InjuryJun 13, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT LEADS REPOSITIONING AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 22201508 ↗
• InjuryJun 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD IMPEDANCES. IT WAS ALSO NOTED THAT PATIENT EXPERIENCED UNWANTED SENSATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22187594 ↗
• MalfunctionJun 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS WERE REPLACED WITH AN MRI COMPATIBLE DEVICE DUE TO LEAD FRACTURE. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165469 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SPINAL CORD STIMULATOR LEAD WAS EXPLANTED FOR UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049471 ↗
• InjuryMay 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SCS SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RELEASED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989838 ↗
• InjuryMay 5, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) LEADS WERE EXPLANTED DUE TO IMPEDANCES. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED. THE LEADS WERE DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

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

  MAUDE report 21965076 ↗
• InjuryFeb 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD HAD IMPEDANCE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333595 ↗
• InjuryJan 10, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL SPINAL CORD STIMULATION (SCS) LEAD CONTACTS WITH HIGH IMPEDANCES, AND THE PATIENT EXPERIENCED SHOCKING STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DEVICE WAS IMPLANTED, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 21127666 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848048 ↗
• InjuryOct 24, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 20526789 ↗
• InjuryOct 22, 2024High impedance; Unexpected Therapeutic Results; Charging Problem; High impedance; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEAD. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT 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 20501745 ↗

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-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-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-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-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
• 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.