Click™ SC-4316Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 08714729793267), received between Dec 15, 2016 and Aug 24, 2026 — classified as 61 injuries.

The most frequently reported specific device problem is “Migration” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) underwent a system replacement procedure. Information regarding the original reason for the anchor revision is unavailable per customer or account. The patient is reported to be doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408018 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE ANCHOR SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE TUNNELED DEEPER USING THE SAME CLICK ANCHORS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 24544713 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) ANCHOR WAS IRRITATING THE PATIENT. THE PATIENT UNDERWENT AN ANCHOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23711796 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN ATTRIBUTED TO THE ANCHOR PLACEMENT. THE PATIENT UNDERWENT AN ANCHOR REVISION PROCEDURE WHEREIN THEIR ANCHOR WAS EXPLANTED AND REPLACED. THE ANCHOR WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL, NO ISSUES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 23527488 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT SITTING FLAT PUSHING INTO THE PATIENTS SKIN AND THE CLIK ANCHORS WERE CAUSING THEM PAIN. THE PATIENT ALSO NOTED THAT THE IPG WAS MOVING AROUND INSIDE THE POCKET SITE CAUSING THEM CHARGING DIFFICULTIES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REVISION PROCEDURE WHERE THE LEADS AND CLIK ANCHORS WERE REPLACED. THE IPG WAS ALSO REPOSITIONED DURING THE PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 22543357 ↗
• InjuryMay 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND MUSCLE SPASMS AT THE LEAD ANCHOR SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS BURIED DEEPER AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Cramp(s) /Muscle Spasm(s); Implant Pain

  MAUDE report 22082925 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DETERIORATION OF THEIR SCS IMPLANT WOUND SITE WHERE THE CLIK ANCHOR AND A SMALL PORTION OF THE LEAD HAS EXTRUDED THROUGH THE SKIN BECOMING EXPOSED. THEREFORE, THE PATIENT WAS REFERRED TO A WOUND CLINIC AND WAS GIVEN ANTIBIOTIC MEDICATION AND A CULTURE WAS TAKEN. NO DYSPLASTIC PATHOLOGIES OR MALIGNANCY WERE IDENTIFIED. THE PATIENT ALSO UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE FULL SCS SYSTEM WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 21542245 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HEMATOMA, PAIN, AND A RED BUMP THAT WAS NOT HEALING AT THE ANCHOR SITE. THE PHYSICIAN DRAINED THE AREA UNDER X-RAY. FOLLOWING THE PROCEDURE, PUS WAS NOTED AT THE ANCHOR SITE AND INFECTION DEVELOPED AT THE BATTERY SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS ADMINISTERED WITH ANTIBIOTICS. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Bacterial Infection; Hematoma; Impaired Healing; Implant Pain; Purulent Discharge

  MAUDE report 21227808 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE CLIK ANCHOR SITE AND HAD AN INJECTION WITH NO RELIEF. NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS CLIK ANCHOR AND PADDLE LEAD WAS BECOMING SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR AND PADDLE LEAD WAS PLACED DEEPER.

  Patient problems: Implant Pain

  MAUDE report 20045272 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS MID BACK ANCHOR INCISION SITE HAD SOME DRAINAGE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 20027676 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE CLIK ANCHOR SITE. THE PATIENT WAS GIVEN A LIDOCAINE PATCHES OVER THE ANCHOR SITE. ADDITIONAL INFORMATION WAS RECEIVED THAT CLIK ANCHOR WAS EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL PSOTOPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 19903989 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DUE TO THE ANCHOR MIGRATING AND POKING OUT TOWARDS THE SURFACE OF THE SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS BURIED DEEPER INTO THE PATIENTS BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 19669190 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN PICKING AND SCRATCHING AT THE SPINAL CORD STIMULATION CERVICAL LEAD ANCHOR SITE. THE PHYSICIAN NOTED THAT ONE OF THE LEAD ANCHOR SUTURE STITCHES WAS SLIGHTLY PROTRUDING THROUGH THE SKIN AT THE SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE PHYSICIAN CAREFULLY CUT AND BURIED THE ANCHOR DEEPER. THE PATIENT WAS DISCHARGED AND DOING WELL POSTOPERATIVELY. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. THE PHYSICIAN ASSESSED THE EVENT HAD NOTHING TO DO WITH THE DEVICE.

  Patient problems: Erosion

  MAUDE report 19231863 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ANCHOR WAS COMING OUT OF THE PATIENTS SKIN, AND INFECTION AND PUS WAS NOTED AT THE SITE. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT DEVICE RELATED, HOWEVER THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PRESCRIBED ANTIBIOTICS. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Erosion; Purulent Discharge

  MAUDE report 18370551 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT THAT WAS CAUSED BY THE ANCHORS. IT WAS ALSO REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT DEVICE REVISION PROCEDURE WHEREIN THE ANCHORS AND LEADS WERE REPLACED, AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISPOSED BY THE FACILITY.

  Patient problems: Discomfort

  MAUDE report 17887412 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS ANCHOR WAS POKING OUT OF THE MIDLINE INCISION SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND ALL DEVICE COMPONENTS WERE NOT RETURNED.

  Patient problems: Erosion

  MAUDE report 17263854 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE CLIK ANCHOR SITE. THE PATIENT UNDERWENT A CLIK ANCHOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort

  MAUDE report 17140270 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE CLIK ANCHOR SITE. X-RAY SHOWED THAT THE CLIK ANCHOR WAS CLOSE TO THE SPINOUS PROCESS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR WAS MOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINED IMPLANTED.

  Patient problems: Discomfort

  MAUDE report 16704740 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PROTRUSIONS AT THE THORACIC INCISION WHICH FELT LIKE THE ANCHOR NEAR THE SKIN. THIS WAS CAUSING DISCOMFORT AND PAIN. IT WAS ALSO NOTED THAT THE PATIENT HAS BEEN LOSING WEIGHT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CIK ANCHOR WAS REPOSITIONED DEEPER INTO TISSUE AND REMAINED IMPLANTED.

  Patient problems: Discomfort; Erosion; Pain

  MAUDE report 16185918 ↗
• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT SYMPTOMS TO WHICH THE DOCTOR DISCOVERED THE ABANDONED ANCHORS. THE PHYSICIAN REMOVED THE CLIK ANCHORS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: Discomfort; Pain

  MAUDE report 16077753 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE UPPER THORACIC INCISION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEFT CLIK ANCHOR WAS REPLACED WITH SUTURE SLEEVES.THE EXPLANTED CLIK ANCHOR WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 15567771 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WAS EXPERIENCING DISCOMFORT AT THE ANCHOR SITE. THE PATIENT UNDERWENT AN CLICK ANCHOR EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 14889552 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS ANCHOR SITE WAS SUPERFICIAL AND WAS CAUSING DISCOMFORT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED ANCHOR WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 14382399 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE MIDLINE INCISION SITE. THE PATIENT UNDERWENT A (I&D) INCISION AND DRAINAGE TO WASH OUT THE WOUND AND BURIED THE ANCHORS DEEPER. THE PATIENTS INCISION SITE WAS WELL HEALED WITH NO SIGNS OF DRAINAGE.

  Patient problems: Discomfort; Pain

  MAUDE report 13505107 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE LEAD INCISION SITE WHERE THE ANCHOR IS LOCATED DUE TO WEIGHT LOSS. THE PATIENT WAS FEELING AN IRRITATING STIMULATION DUE TO THE A NON DEVICE RELATED CYST IN THE EPIDURAL SPACE. THE PATIENT UNDERWENT AN ANCHOR REPLACEMENT PROCEDURE WHEREIN A SMALL SILICONE ANCHOR WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND EXPLANTED ANCHOR WILL NOT BE RETURNED.

  Patient problems: Implant Pain; Skin Inflammation/ Irritation

  MAUDE report 12391238 ↗

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-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-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-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-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-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.