Infinion™ Pro SC-2318-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00191506018726), received between Oct 14, 2024 and Sep 30, 2026 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (21 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 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient was experiencing loss of efficiency from the spinal cord stimulator (SCS). It was also stated that the patient's right spinal cord stimulator (SCS) lead had migrated two vertebral bodies which was confirmed through Xray. The patient had a device optimization was done without success. The patient underwent a lead replacement procedure and the patient was doing well postoperatively. The explanted lead was discarded by the medical facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50942711 ↗
• InjuryAug 19, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333781 ↗
• InjuryJul 6, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE FOR LOW BACK COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE NOT RETURNED PER FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 25719196 ↗
• MalfunctionJul 3, 2026Device Fell

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD WAS DROPPED TO THE FLOOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25707119 ↗
• InjuryJun 23, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION AND THE LEADS HAD MIGRATED OUT OF THE EPIDURAL SPACE. 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 25589179 ↗
• InjuryMay 13, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION ON NON TARGET AREA. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN ONE OF THE LEADS WAS EXPLANTED AND THE OTHER LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25160533 ↗
• InjuryApr 26, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND CLIK ANCHOR WERE REPLACED AND RELOCATED DUE TO INADEQUATE STIMULATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED PRODUCTS WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 24993508 ↗
• InjuryApr 17, 2026Charging Problem; Migration

  IT WAS REPORTED THAT PATIENT FELL AND THE LEADS HAD MIGRATED. THE PATIENT EXPERIENCED CHARGING ISSUES WITH THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916885 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND FELT THE LEADS WERE STICKING OUT. IT WAS NOTED THAT PATIENT HAD A NON-DEVICE RELATED WEIGHT LOSS AND COULD FEEL WHERE THE ANCHOR WAS IN THE BACK. IT WAS ALSO MENTIONED THAT THE PATIENT FELT LIKE THE WIRES WERE BUNCHED UP. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) LEADS AND CLIK ANCHOR WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Erosion; Pain

  MAUDE report 24789139 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK DURING THE IMPLANT PROCEDURE WHEN THE PHYSICIAN TRIED TO ENTER THE EPIDURAL SPACE USING AN ENTRADA NEEDLE. A BLOOD PATCH WAS PERFORMED, AND THE PATIENT WAS KEPT IN A FLAT LAYING DOWN POSITION FOLLOWING THE PROCEDURE. THE PATIENT WAS DOING WELL UPON FOLLOW-UP.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24631861 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEW DISCOMFORT IN THE LEG FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN OPTED FOR A LEAD REPLACEMENT, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 24628336 ↗
• InjuryFeb 17, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT PATIENTS LEFT LEAD WAS CAUSING TO HAVE MOTOR STIM OR POSSIBLY INTRATHECAL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24367713 ↗
• InjuryFeb 2, 2026Migration

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD AND ANCHOR REPLACEMENT PROCEDURE. NOTHING WILL BE RETURNED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234869 ↗
• InjuryJan 29, 2026Nonstandard Device; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 24210688 ↗
• InjuryJan 28, 2026Migration

  IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200242 ↗
• InjuryJan 5, 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 LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Pain

  MAUDE report 23959069 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEADS WERE REPLACED TO COVER NEW PAIN AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875597 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CEREBROSPINAL FLUID LEAKAGE (CSF LEAK) AND HAD A BLOOD PATCH. THE PATIENT WAS DOING WELL POSTOPERATIVELY. PHYSICIAN ABORTED THE CASE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23821624 ↗
• InjuryDec 11, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) LEADS WERE REPLACED DUE TO MIGRATION, WHICH SUBSEQUENTLY RESULTED IN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: Pain

  MAUDE report 23783869 ↗
• InjuryDec 3, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD MIGRATED OUT OF THE EPIDURAL SPACE WHICH CAUSED THE PATIENT TO EXPERIENCE LOSS OF STIMULATION. THE PATIENT UNDERWENT A SCS REVISION PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 23708299 ↗
• InjuryNov 28, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO SPINAL CORD STIMULATION (SCS) LEADS MIGRATION AS CONFIRMED THRU XRAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 23673961 ↗
• InjuryNov 26, 2025Migration; Migration

  IT WAS REPORTED THAT THE DISTAL TIP OF THE SPINAL CORD STIMULATOR (SCS) LEAD HAD MIGRATED AND EXTRUDED ON THE SCALP. THE PATIENT UNDERWENT A SCS LEAD REVISION AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Erosion

  MAUDE report 23660833 ↗
• InjuryNov 19, 2025Migration; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD MIGRATED. IMAGING WAS ACQUIRED TO CONFIRM SCS LEAD MIGRATION. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600702 ↗
• InjuryOct 17, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING. IT WAS ALSO STATED THAT ONE OF THE PATIENTS LEAD HAD MIGRATED CAUSING INTERMITTENT BURNING SENSATION AT THE LOWER BACK. XRAY WERE PERFORMED TO CONFIRM LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 23322567 ↗
• MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PERMANENT PROCEDURE, THE CASE WAS ABORTED DUE TO THE PATIENT EXPERIENCING LOW OXYGEN LEVELS. NOTHING WAS IMPLANTED, AND THE ISSUE WAS NOT DEVICE RELATED. THE PATIENT WAS DOING WELL. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304991 ↗

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-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-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-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.