Infinion™ CX SC-2317-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,268 adverse event reports that list this exact device (DI 08714729861638), received between Jan 11, 2017 and Sep 28, 2026 — classified as 1 death, 1,128 injuries, 139 malfunctions.

The most frequently reported specific device problem is “High impedance” (795 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 1,268 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Unexpected Therapeutic Results; Charging Problem; Migration

  Patient problems: Pain

  MAUDE report 50923928 ↗
• MalfunctionSep 28, 2026High impedance; Migration

  It was reported that after a fall, it was found out that the right lead had two impedances and the lead had possibly migrated but was unable to confirm it. After program optimization, the patient got good coverage.

  Patient problems: Fall

  MAUDE report 50910714 ↗
• InjurySep 23, 2026High impedance

  Patient problems: Discomfort; Pain

  MAUDE report 50874514 ↗
• InjurySep 19, 2026Fracture; High impedance; Unexpected Therapeutic Results; Migration

  Patient problems: Pain

  MAUDE report 50831660 ↗
• InjurySep 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831298 ↗
• InjurySep 18, 2026High impedance; Unexpected Therapeutic Results

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

  MAUDE report 50828714 ↗
• InjurySep 17, 2026High impedance; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812338 ↗
• InjurySep 15, 2026High impedance

  It was reported that the patient had high impedances on the leads. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure. The explanted products will not be returned per hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767166 ↗
• InjuryAug 28, 2026High impedance

  It was reported tha the patient had a new area of pain in her upper back, and the leads had high impedances. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure.Additional information was received that the explanted products were discarded per hospital policy and patient was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50509726 ↗
• InjuryAug 28, 2026High impedance

  It was reported that the leads had high impedances. The patient underwent a Spinal Cord Stimulator (SCS) system explant procedure and was doing well postoperatively. The explanted devices were discarded by the facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50490374 ↗
• InjuryAug 19, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient was no longer getting a relief due to lead migration that was confirmed via X-ray. All components were explanted. No further information has been obtained.

  Patient problems: Pain

  MAUDE report 50315445 ↗
• InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate pain relief. The patients battery was moving more laterally away from her spine and leads had high impedances. The patient underwent spinal cord stimulation (SCS) replacement procedure. The patient was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50290597 ↗
• InjuryAug 10, 2026High impedance; Unexpected Therapeutic Results

  It was reported that the patient was not getting pain relief due to high impedances on the Spinal Cord Stimulation (SCS) leads. BSN sales representative was able to program around impedances, however patient opted to undergo a procedure wherein a full system was replaced. The patient was doing well postoperatively, and the explanted devices were disposed of.

  Patient problems: Pain

  MAUDE report 50196803 ↗
• InjuryAug 6, 2026High impedance

  It was reported that the patients Spinal Cord Stimulator (SCS) leads exhibited high impedance measurements. Although adequate stimulation coverage was maintained, the patient required Magnetic Resonance Imaging (MRI) compatibility. As a result, the patient underwent an SCS system replacement procedure and was doing well postoperatively. The explanted device components were not returned due to facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159404 ↗
• InjuryAug 4, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  It was reported that the patient occasionally felt electric shocks and a sensation of pressure or sharp pain in the mid back area. The spinal cord stimulation (SCS) leads displayed high impedances. Re-programming was performed multiple times, however it did not resolve the issue. Imaging performed determined that the leads were rotated and laterally displaced. The patient underwent a revision procedure where the leads were removed and replaced. The procedure was completed without complications, and the patient subsequently experienced a favorable clinical outcome with resolution of the symptoms. The physician concluded that the event was not related to the performance or functionality of the leads, but rather to their anatomical positioning, as the leads were found to be laterally displaced. Consequently, the explanted leads were discarded and were not returned for product analysis.

  Patient problems: Device Overstimulation of Tissue; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50135786 ↗
• InjuryJul 29, 2026High impedance

  It was reported that the leads had high impedances. The patient underwent a revision procedure wherein the leads were replaced and the anchoring device was removed. The patient was doing well postoperatively and the explanted devices were not released by the medical facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077672 ↗
• InjuryJul 27, 2026High impedance; Unexpected Therapeutic Results

  It was reported that patients spinal cord stimulator lead had high impedances. It was noted that patient was not able to get enough pain relief. The patient underwent a Spinal Cord Stimulator (SCS) replacement procedure. The explanted device will not be returned due to facility policy.

  Patient problems: Pain

  MAUDE report 50001090 ↗
• InjuryJul 22, 2026High impedance

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIGH IMPEDANCES DETECTED IN THE LEAD. TO ADDRESS THIS, THE LEAD WAS REMOVED AND REPLACED. POSTOPERATIVELY, THE PATIENT IS RECOVERING WELL. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908382 ↗
• InjuryJul 17, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864055 ↗
• InjuryJul 10, 2026High impedance

  IT WAS REPORTED THAT SEVERAL IMPEDANCES WERE NOTED ON THE LEAD AND PATIENT EXPERIENCED A RIB STIMULATION. 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: Inappropriate Device Stimulation of Tissue

  MAUDE report 25786365 ↗
• InjuryJul 1, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 25681132 ↗
• InjuryJun 30, 2026High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A 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 25673434 ↗
• InjuryJun 7, 2026High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION AFTER A FALL AND THE LEADS HAD HIGH IMPEDANCES. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 25422446 ↗
• InjuryJun 1, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENTS LEAD DISPLAYED HIGH IMPEDANCE, AND THE PATIENT EXPERIENCED MINOR PAIN AND A SHOCKING SENSATION AT THE LEAD SITE INTERMITTENTLY.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 25349958 ↗
• InjuryMay 29, 2026High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336458 ↗

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-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-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-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-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.