Clik™ X SC-4318Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 08714729905318), received between Dec 29, 2016 and Sep 28, 2026 — classified as 93 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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 16, 2026.

Recalls naming this device

1. Apr 29, 2026Open, Classified

   Sterile anchors my lack sterility assurance.

   Z-2404-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Nonstandard Device

  Patient problems: Implant Pain; Weight Changes

  MAUDE report 50915808 ↗
• InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available

  The patient experienced discomfort at the implant site, described as sharp and aching pain occurring daily along with generalized weakness in the legs. The patient also reported being unable to wear a belt because it contacted the painful area. The patient continued taking pregabalin, which was reported to be helpful. Imaging confirmed that the leads had migrated causing discomfort near the anchor site. The patient underwent a lead replacement procedure. The patient was reported to be doing well postoperatively. The facility kept the explanted product.

  Patient problems: Discomfort; Fall; Muscle Weakness/Atrophy; Numbness; Pain; Seroma

  MAUDE report 50786561 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain and discomfort in the back at the location of the anchor due to weight loss. As a result, the patient underwent a revision procedure wherein the anchor was removed from the linear leads, and the leads were secured directly using Ethibond suture. The patient was doing well postoperatively, and the explanted device was not returned as it was discarded by the medical facility.

  Patient problems: Back pain; Discomfort; Weight Changes

  MAUDE report 50168582 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WOUND OVER THE CLIK ANCHOR SITE WAS NOT HEALING PROPERLY AND THE INTERNAL SUTURES SEEM TO BE WORKING OUT OF SKIN.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25513664 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THIS ANCHOR KIT PACKAGING WAS NOTED NOT TO BE SEALED. BECAUSE THE STERILITY OF THE PRODUCT WAS IN QUESTION, THIS PRODUCT WAS NOT USED AND WAS PLANNED TO BE RETURNED FOR ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018043 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THIS ANCHOR KIT WAS VISUALLY EXAMINED PRIOR TO USE IN A SURGICAL PROCEDURE, ONE OF THE ANCHORS APPEARED TO BE DISCOLORED, WITH A BROWN HUE, ON THE INSIDE. THIS ANCHOR KIT WAS NOT USED AND ANOTHER KIT WAS USED INSTEAD. THREE GOOD FAITH EFFORTS WERE COMPLETED WITH REQUESTS FOR THE PRODUCT TO BE RETURNED. NO RESPONSE WAS RECEIVED AND THE PRODUCT HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017842 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) ANCHOR REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE SCS ANCHORS REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830547 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT IS EXPERIENCING DISCOMFORT AT THE LEAD ANCHOR SITE, ATTRIBUTED TO WEIGHT LOSS. THERE IS NO INDICATION OF DEVICE MALFUNCTION, AND STIMULATION REMAINS EFFECTIVE. AS A RESULT, A REVISION PROCEDURE HAS WAS PERFORMED TO REPOSITION THE LEAD ANCHORS TO A DEEPER LOCATION. DURING SURGERY, MINOR AMOUNT OF BIPOLAR ELECTROCAUTERY WAS USED. POST OPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED.

  Patient problems: Discomfort; Weight Changes

  MAUDE report 24730440 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PAIN AT THE MIDLINE ANCHOR SITE. THE PATIENT UNDERWENT A LEAD AND CLIK ANCHOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 23907809 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE ANCHOR SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS BURIED DEEPER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS REMOVED OR ADDED.

  Patient problems: Discomfort

  MAUDE report 23896900 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT ALSO HAD DISCOMFORT AT ANCHORS SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR ANCHOR REPOSITIONING PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

  Patient problems: Discomfort

  MAUDE report 23295534 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR CLICK ANCHOR HAD ERODED. THE PATIENT UNDERWENT A PROCEDURE WHERE IN PHYSICIAN OPTED TO OPEN THE MIDLINE INCISION AND CLEANED EVERYTHING OUT, THEN PHYSICIAN CLOSED THE INCISION. THE PATIENT WAS SENT HOME AND WAS GIVEN ANTIBIOTICS FOR PRECAUTIONS.

  Patient problems: Erosion

  MAUDE report 22671802 ↗
• InjuryJul 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Burning Sensation; Discomfort; Undesired Nerve Stimulation

  MAUDE report 22645028 ↗
• InjuryJul 3, 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 STIMULATION (SCS) EXPLANT PROCEDURE DUE TO A KNOT AT THE SUTURE LINE THAT LOOKS LIKE THE CLICK ANCHOR. THE PATIENT DOING WELL POSTOPERATIVELY. EXPLANTED DEVICE WAS RETURNED AS IT WAS KEPT BY THE FACILITY.

  Patient problems: Erosion; Swelling/ Edema

  MAUDE report 22400311 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AT THE SPINAL CORD STIMULATION CLIK ANCHOR SITE. THE PATIENT EXPERIENCED THE PAIN WHEN THE STIMULATION WAS BOTH ON AND OFF. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE CLIK ANCHOR WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED CLIK ANCHOR WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Discomfort; Pain

  MAUDE report 22293974 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPH INFECTION THAT STARTED IN THE BATTERY SITE AND TRAVELED INTO THE MIDLINE INCISION AND INTO ANCHORS. SYMPTOMS OF FEVER, REDNESS AND INFLAMMATION. A STITCH POOPED THROUGH THE SKIN WAS THE CAUSE ON THE INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

  Patient problems: Bacterial Infection; Erythema; Fever; Inflammation

  MAUDE report 21973375 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLIK X ANCHOR WAS PROMINENT IN THE BACK. THE PATIENT UNDERWENT A PROCEDURE WHERE THE CLIK X ANCHOR WAS REPOSITIONED AND BURIED DEEPER SO IT WAS LESS PROMINENT. POST OPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929385 ↗
• InjuryApr 2, 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 DISCOMFORT AND PAIN AT THE ANCHOR SITE, THE PATIENT UNDERWENT A PROCEDURE IN WHERE THE ENTIRE SYSTEM WAS EXPLANTED. ELECTROCAUTERY WAS USED. THE PATIENT IS RECOVERED POST OPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURN AS THEY WERE RETAINED PER FACILITY POLICY.

  Patient problems: Discomfort; Pain

  MAUDE report 21758595 ↗
• InjuryMar 12, 2025Application Program Problem; Adverse Event Without Identified Device or Use Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SWELLING AND REDNESS AT THE ANCHOR SITE DUE THE POSSIBILITY THAT THE PATIENT'S BODY WAS REJECTING THE ANCHOR. IT WAS NOTED THAT THE PATIENT'S CLICK ANCHORS WERE PALPABLE CAUSING PAIN AND DISCOMFORT AT THE MIDLINE INCISION SITE PREVENTING THE PATIENT TO LAY FLAT ON THE BACK OR SIT STRAIGHT. MULTIPLE REPROGRAMMING WERE MADE BUT CAUSED THE PATIENT LEGS TO FRAZZLE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Discomfort; Erythema; Implant Pain; Pain; Shaking/Tremors; Swelling/ Edema

  MAUDE report 21586257 ↗
• InjuryFeb 10, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD ANCHOR SITE. IT WAS NOTED THAT THE ANCHOR WAS VISIBLE THROUGH THE SKIN. IT WAS ALSO REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Erosion; Pain

  MAUDE report 21349382 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED PAIN AT THE MIDLINE INCISION SITE. THE PHYSICIAN EXAMINED THE PATIENT AND BELIEVED THAT THE STITCH COULD POSSIBLY BE TOO TIGHT AROUND THE ANCHOR. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE STITCH AROUND THE ANCHOR WAS ADJUSTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Implant Pain

  MAUDE report 21337589 ↗
• InjuryDec 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS ANCHOR WAS SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS MOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE ANCHOR REMAINS IMPLANTED IN THE PATIENT AND IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032114 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ANCHOR MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164089 ↗
• InjuryAug 12, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF, MUSCLE SPASMS AND PAIN AROUND THE SPINAL CORD STIMULATOR (SCS) ANCHORS. IT WAS ALSO NOTED THAT THE PATIENTS SCS LEADS HAD MIGRATED. THE PATIENT WAS GIVEN PAIN MEDICATIONS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG, LEADS AND CLIK ANCHOR WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

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

  MAUDE report 19961713 ↗
• InjuryJul 20, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HEARD A POP IN THE BACK AND A SUDDEN LOSS OF STIMULATION. IT WAS NOTED THAT THE LEAD HAD MIGRATED DUE TO THE ANCHOR DISLODGING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS REPLACED, AND ONE LEAD EXTENSION WAS ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED.

  Patient problems: Pain

  MAUDE report 19787262 ↗

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-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-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-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-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-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.