Infinion™ Pro SC-2318-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00191506018733), received between Oct 5, 2024 and Sep 30, 2026 — classified as 1 death, 41 injuries, 4 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 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance

  It was reported that during an implant procedure, the physician could not clear up the high impedances on the lead. The physician opted to use a new lead, and impedances were all green and clear.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942447 ↗
• InjurySep 25, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898459 ↗
• InjurySep 15, 2026High impedance

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50780726 ↗
• InjurySep 15, 2026Unexpected Therapeutic Results; Migration

  It was reported that X-ray revealed that the left lead had migrated down and patient had an inadequate stimulation as a result. It was attempted to push the lead back into place but was unsuccessful. The physician opted to explant the lead along with the clik anchor. A new clik anchor was put in. The explanted products will not be returned per hospital policy, and patient was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50766985 ↗
• InjurySep 14, 2026Migration

  Patient problems: Fall

  MAUDE report 50765613 ↗
• InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results; Migration

  It was reported that the patient was not feeling any relief and leads had impedances and migrated. The patient underwent lead repositioning procedure. Patient was doing great postoperatively.

  Patient problems: Pain

  MAUDE report 50311695 ↗
• MalfunctionAug 11, 2026Migration

  It was reported that the patient experienced lead migration due to a fall. It was noted that lead migration was confirmed through imaging, however, the patient still received good stimulation coverage.

  Patient problems: Fall; Unspecified Respiratory Problem

  MAUDE report 50202725 ↗
• InjuryAug 6, 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 50164257 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient developed an infection at the anchor site. The patient had symptoms of redness, swelling, tenderness, and a temperature. There were no device issues, however, the patient underwent an explant procedure to have all devices explanted. The patient was also treated with antibiotics. At the post-op wound review, there were no signs of infection and the patient was healing as expected with no further complications. A culture was performed but results were not provided. The physician stated that it was most likely a superficial infection from the incision. All explanted devices were discarded by the medical facility.Additional information was received that cultures were taken and it was indicative of a skin infection. However, the physician assessed that the infection was not related to any of the devices but rather something the patient managed to pick up.

  Patient problems: Erythema; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 25089322 ↗
• InjuryApr 28, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED STIMULATION ON THE ABDOMEN AND RIBS DUE TO THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE DEVICE MIGRATION WAS CONFIRMED THRU X-RAY IMAGING. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25017865 ↗
• InjuryApr 17, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPOSITION PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING REMOVED OR ADDED.

  Patient problems: Pain

  MAUDE report 24916467 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MICRO-INFECTION AT THE LEAD INSERTION SITE. THE PHYSICIAN ASSESSED THAT GIVEN THE PATIENTS SIGNIFICANT POSTERIOR SCOLIOSIS, IT WAS NOTED THAT THE MIDLINE INCISION AT THE LEAD INSERTION SITE MAY HAVE BEEN SUBJECTED TO PERSISTENT CONTACT WITH THE SPINOUS PROCESS AND ANCHOR COMPONENTS, POTENTIALLY CAUSING SKIN ABRASION. THE SKIN AT THE LEAD INSERTION SITE HAD WORN AWAY, LEAVING A SMALL OPEN WOUND. THIS NECESSITATED PARTIAL DEBRIDEMENT AS AN OUTPATIENT PROCEDURE. THE PATIENTS MIDLINE INCISION ALONG THE SPINOUS PROCESS AT THE LEAD INSERTION SITE WAS REOPENED AND THE WOUND WAS IRRIGATED WITH POVIDONE-IODINE SOLUTION. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Erosion; Localized Skin Lesion; Unspecified Infection

  MAUDE report 24634518 ↗
• InjuryMar 13, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. X-RAY IMAGING CONFIRMED THE DEVICE MIGRATION. THE PATIENT UNDERWENT A SCS LEADS REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 24590526 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE WHICH CAUSED FEVER, DRAINAGE, REDNESS AND IMPAIRED HEALING AT THE INCISION SITE. THE PATIENT WAS PROVIDED WITH PROPHYLACTIC ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: Bacterial Infection; Fever; Fluid Discharge; Impaired Healing

  MAUDE report 24581494 ↗
• InjuryMar 11, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE ANCHOR SITES. X-RAY SHOWED MIGRATION OF BOTH SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT WAS ADMINISTERED WITH INJECTION FOR PAIN.

  Patient problems: Pain

  MAUDE report 24573189 ↗
• InjuryMar 6, 2026Migration

  IT WAS REPORTED THAT THE LEADS HAD MIGRATED AND WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528510 ↗
• InjuryMar 4, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THE SPINAL CORD STIMULATOR (SCS) LEAD HAD MULTIPLE CONTACTS THAT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Pain

  MAUDE report 24505908 ↗
• InjuryJan 7, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987402 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DRAINING INCISION AT THE LEAD INCISION SITE. ALL COMPONENTS WERE EXPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Fluid Discharge

  MAUDE report 23907869 ↗
• InjuryDec 22, 2025Migration; Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED OUT OF HIS EPIDURAL SPACE WHICH WAS CONFIRMED USING FLUOROSCOPY. THE PATIENT UNDERWENT LEAD REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873913 ↗
• InjuryDec 22, 2025Unexpected Therapeutic Results; Migration; 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 PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 23861544 ↗
• MalfunctionDec 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) HAD FRACTURED AND WAS CONFIRMED BY X-RAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23829790 ↗
• MalfunctionDec 16, 2025High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) HAD FRACTURED AND WAS CONFIRMED BY X-RAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 23821684 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, WHILE THE PATIENT WAS UNDER SEDATION, THE PHYSICIAN WAS PLACING THE RIGHT LEAD WHEN THE PATIENTS HEART RATE BEGAN TO DECREASE. MEDICATIONS WERE ADMINISTERED BY THE ANESTHESIA TEAM, BUT THE HEART RATE CONTINUED TO DECLINE, RESULTING IN CARDIAC ARREST. THE IMPLANTING PHYSICIAN REMOVED THE LEADS, AND EMERGENCY RESUSCITATION EFFORTS COMMENCED. THE PATIENT WAS INTUBATED IN THE OPERATING ROOM. EMERGENCY MEDICAL SERVICES WERE CONTACTED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT KNOW THE CAUSE OF DEATH. THE PATIENT DID NOT HAVE ANY COMORBIDITIES WHICH WERE BELIEVED TO HAVE CONTRIBUTED TO THE PATIENTS DEATH. IT WAS NOTED THAT AFTER THE PATIENT WAS PLACED ON A VENTILATOR, THE PATIENTS CODE STATUS WAS EVENTUALLY CHANGED TO DO NOT RESUSCITATE (DNR) AT THE FAMILY REQUEST.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 23739429 ↗
• InjuryDec 4, 2025High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE EXPLANTED DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

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

  MAUDE report 23722518 ↗

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-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-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-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-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.