Infinion™ CX SC-2317-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 871 adverse event reports that list this exact device (DI 08714729861614), received between Jan 2, 2017 and Sep 22, 2026 — classified as 736 injuries, 135 malfunctions.

The most frequently reported specific device problem is “High impedance” (511 reports).

1 FDA recall record name this device's identifier, 1 still open.

16 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.

Recalls naming this device

1. Jun 17, 2026Class IOpen, Classified

   Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

   Z-2879-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 871 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026High impedance; Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50849379 ↗
• InjurySep 21, 2026High impedance; Charging Problem

  It was reported that the patient was unable to have a Magnetic Resonance Imaging (MRI) due to concern for abnormal lead impedance from the Spinal Cord Stimulator (SCS) device. It was also reported that the patients Implantable Pulse Generator (IPG) was no longer keeping a charge. The patient underwent a revision procedure wherein the IPG, SCS leads and Clik anchor were replaced. The patient was reported to be doing well post operatively. The explanted device components were not returned due to facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836113 ↗
• InjuryAug 21, 2026Unexpected Therapeutic Results; Charging Problem

  Patient problems: Implant Pain; Pain

  MAUDE report 50383810 ↗
• InjuryAug 14, 2026High impedance; Unexpected Therapeutic Results; Charging Problem

  Patient problems: Pain

  MAUDE report 50260564 ↗
• InjuryAug 14, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient experienced inadequate stimulation despite multiple program optimization attempts. It was confirmed through imaging that the leads had migrated. As a result, the patient underwent a procedure where the physician realigned the Spinal Cord Stimulator (SCS) leads in a better position. The patient was reported to be doing well postoperatively. The SCS leads remain implanted and in use.

  Patient problems: Pain

  MAUDE report 50254230 ↗
• InjuryAug 13, 2026High impedance; Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate stimulation and charging issues due to high impedances on the right lead. Program optimization was attempted and was unsuccessful. As a result, the patient underwent a revision procedure wherein the Spinal Cord Stimulator (SCS) lead and Implantable Pulse Generator (IPG) were replaced. The patient was reported to be doing well postoperatively. The explanted devices were not returned.

  Patient problems: Pain

  MAUDE report 50234762 ↗
• InjuryJul 28, 2026High impedance; Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient experienced a non-device related fall, after which the Spinal Cord Stimulator (SCS) leads exhibited new impedances, which resulted in inadequate pain relief. It was also noted that the patient experienced difficulty charging the Implantable Pulse Generator (IPG), including a need for frequent charging. As a result, the patient underwent a procedure wherein the SCS leads, IPG, and Clik anchor were replaced. The patient was doing well postoperatively, and the explanted device components were not returned due to facility policy.

  Patient problems: Pain

  MAUDE report 50059523 ↗
• InjuryJul 16, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES AND THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Pain

  MAUDE report 25841677 ↗
• InjuryJun 25, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEADS AND CLICK ANCHOR EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL AND THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630716 ↗
• MalfunctionJun 18, 2026Fracture; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS WERE FRACTURED AND 11 CONTACTS WERE OUT. IT WAS ALSO STATED THAT THE PATIENT WAS NOT GETTING COVERAGE ON ALL PAIN AREAS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Implant Pain

  MAUDE report 25550656 ↗
• InjuryJun 4, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) LEADS HAD MULTIPLE IMPEDANCE FOLLOWING A FALL. 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: Pain

  MAUDE report 25391396 ↗
• InjuryMay 23, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE SURGERIES FOR LOOSE WIRES, LEADS DETACHING AND IMPLANTABLE PULSE GENERATOR (IPG) BEING LOOSE. IT WAS NOTED THAT THE PATIENT WAS TIRED OF BEING CUT OPEN TO REPLACE THINGS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF. THE PATIENT SUBSEQUENTLY UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

  Patient problems: Pain

  MAUDE report 25265024 ↗
• InjuryMay 21, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) 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 25248302 ↗
• InjuryMay 19, 2026High impedance; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPEDANCE ON THE LEAD WHICH IMPACTED THE EFFECTIVENESS OF THE STIMULATION AND ABILITIES TO RECEIVE MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT HAD DIFFICULTY AND FREQUENT CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH SHE ATTRIBUTED TO THE LEAD, AND DESCRIBED THAT THE DEVICE SOMETIMES FAILS TO STAY CONNECTED. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 25225525 ↗
• MalfunctionMay 11, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A LEAD REVISION DUE TO LEAD FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134453 ↗
• InjuryMay 6, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEADS EXPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107154 ↗
• MalfunctionApr 11, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEAD HAS HIGH IMPEDANCES. LEAD FRACTURED WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847361 ↗
• MalfunctionApr 3, 2026Fracture; Use of Device Problem

  IT WAS REPORTED THAT THE DISTAL PART OF ONE OF THE SPINAL CORD STIMULATOR (SCS) LEADS WAS SHEERED AND FRACTURED DURING AN IPG REPLACEMENT PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED AND THAT THE PATIENT WAS DOING WELL WITH GOOD COVERAGE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773918 ↗
• InjuryMar 18, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND SHOCKING SENSATIONS DESPITE OF OPTIMIZING THE PROGRAM. IT WAS NOTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24634832 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIB AND ABDOMINAL STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD REVISION AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24631193 ↗
• InjuryMar 16, 2026High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT HAD HIGH IMPEDANCES AND MIGRATION ON THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LINEAR LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24603886 ↗
• InjuryMar 9, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES DUE TO A NON-DEVICE RELATED FALL. LOSS OF PAIN RELIEF WAS ALSO NOTED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 24553517 ↗
• InjuryMar 6, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528507 ↗
• InjuryFeb 27, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED FOR MRI CAPABILITY. THE PATIENT WAS DOING WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476069 ↗
• InjuryFeb 24, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. IT WAS NOTED THAT THE RIGHT SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REPLACED. NO FURTHER INFORMATION COULD BE OBTAINED.ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 24434622 ↗

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-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-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-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-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
• Z-0299-2007 · Sep 21, 2006 · Terminated
  Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.

…and 1 more.