Evoke® Closed-Loop Stimulator (CLS) 3002 (UDI 09352307001565)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 09352307001565), received between Aug 18, 2023 and Aug 17, 2026 — classified as 2 deaths, 79 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 reports).

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 81 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Insufficient Device Problem Information

  During a full system explant of the Evoke Spinal Cord Stimulation (SCS) System, a cerebrospinal fluid leakage (CSF) occurred. The patient was transported to the hospital, and no additional information was provided. The reason for the full system explant of the Evoke SCS System was not disclosed to Saluda.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50275259 ↗
• InjuryJun 10, 2026Inappropriate/Inadequate Shock/Stimulation

  DURING A MAGNETIC RESONANCE IMAGING (MRI), A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED UNINTENDED STIMULATION. THE MRI WAS SUBSEQUENTLY ABORTED. PRE-MRI GUIDELINES AND DEVICE CHECKS WERE REPORTED TO HAVE BEEN COMPLETED PRIOR TO THE SCAN. A REVISION PROCEDURE WAS PERFORMED, AND THE EVOKE CLOSED LOOP STIMULATOR (CLS) WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 25460369 ↗
• InjuryJun 2, 2026Temperature Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THE EVOKE CLOSED LOOP STIMULATOR (CLS) FELT WARM DURING STIMULATION; THEREFORE, THE CLS HAS BEEN SWITCHED OFF. A REVISION PROCEDURE WAS PERFORMED, AND THE CLS WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25362205 ↗
• InjuryMay 14, 2026Prophylactic removal due to corrective action

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THE PHYSICIAN ELECTED TO EXPLANT THE EVOKE SCS SYSTEM TO ACCOMMODATE AN UNRELATED SURGICAL PROCEDURE. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172868 ↗
• InjuryMay 14, 2026Prophylactic removal due to corrective action

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THE PHYSICIAN ELECTED TO EXPLANT THE EVOKE SCS SYSTEM TO ACCOMMODATE AN UNRELATED SURGICAL PROCEDURE. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172866 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT. THE PATIENT REPORTED RESOLUTION OF THEIR BACK PAIN FOLLOWING CHIROPRACTIC TREATMENT, WHICH WAS PREVIOUSLY MANAGED USING THE SCS THERAPY. THE EVOKE SCS HAS BEEN TURNED OFF FOR THE PAST 24 MONTHS. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172276 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT. THE PATIENT REPORTED RESOLUTION OF THEIR BACK PAIN FOLLOWING CHIROPRACTIC TREATMENT, WHICH WAS PREVIOUSLY MANAGED USING THE SCS THERAPY. THE EVOKE SCS HAS BEEN TURNED OFF FOR THE PAST 24 MONTHS. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172273 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  A SALUDA REPRESENTATIVE WAS REQUESTED TO ATTEND A DEVICE CHECK VISIT PRIOR TO A PATIENT SCHEDULED TO UNDERGO MAGNETIC RESONANCE IMAGING (MRI). DURING THE VISIT, THE PATIENT REPORTED THAT THEY HAD PREVIOUSLY UNDERGONE A FULL SYSTEM EXPLANT AND WERE NO LONGER IMPLANTED WITH AN EVOKE SCS SYSTEM. ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT PROVIDED TO THE SALUDA REPRESENTATIVE. THE EXPLANT PROCEDURE WAS PERFORMED BY A DIFFERENT PHYSICIAN AND AT A DIFFERENT FACILITY THAN THOSE INVOLVED IN THE ORIGINAL IMPLANTATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24966942 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  A SALUDA REPRESENTATIVE WAS REQUESTED TO ATTEND A DEVICE CHECK VISIT PRIOR TO A PATIENT SCHEDULED TO UNDERGO MAGNETIC RESONANCE IMAGING (MRI). DURING THE VISIT, THE PATIENT REPORTED THAT THEY HAD PREVIOUSLY UNDERGONE A FULL SYSTEM EXPLANT AND WERE NO LONGER IMPLANTED WITH AN EVOKE SCS SYSTEM. ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT PROVIDED TO THE SALUDA REPRESENTATIVE. THE EXPLANT PROCEDURE WAS PERFORMED BY A DIFFERENT PHYSICIAN AND AT A DIFFERENT FACILITY THAN THOSE INVOLVED IN THE ORIGINAL IMPLANTATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24966856 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility; Charging Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND CHARGING DIFFICULTY. THE PHYSICIAN NOTED THE PATIENT¿S SIGNIFICANT WEIGHT LOSS AND THE POSITION OF THE EVOKE CLS CONTRIBUTED TO THE REPORTED PAIN AND CHARGING DIFFICULTY. A REVISION PROCEDURE WAS PERFORMED, AND THE PHYSICIAN ELECTED TO REPLACE AND REPOSITION THE EVOKE CLS TO RESOLVE THE REPORTED EVENT.

  Patient problems: Implant Pain

  MAUDE report 24699120 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility; Charging Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND CHARGING DIFFICULTY. THE PHYSICIAN NOTED THE PATIENT¿S SIGNIFICANT WEIGHT LOSS AND THE POSITION OF THE EVOKE CLS CONTRIBUTED TO THE REPORTED PAIN AND CHARGING DIFFICULTY. A REVISION PROCEDURE WAS PERFORMED, AND THE PHYSICIAN ELECTED TO REPLACE AND REPOSITION THE EVOKE CLS TO RESOLVE THE REPORTED EVENT.

  Patient problems: Implant Pain

  MAUDE report 24699116 ↗
• InjuryMar 25, 2026Lack of Effect

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO INADEQUATE PAIN RELIEF SINCE IMPLANTATION. IT WAS NOTED THAT THE PATIENT RECEIVED ADEQUATE RELIEF DURING THE TRIAL PERIOD. TROUBLESHOOTING WAS PERFORMED, INCLUDING REPROGRAMMING, WITHOUT RESOLUTION. AN X-RAY WAS PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE EVOKE SCS SYSTEM WAS EXPLANTED TO RESOLVE THE REPORTED EVENT. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT. FOLLOWING THE EXPLANT PROCEDURE, THE PATIENT REPORTED THAT THEIR CONDITION HAD WORSENED. THE PATIENT DEVELOPED NEW, PROGRESSIVE SPINAL PATHOLOGY. AN X-RAY OBTAINED ON (B)(6) 2025, IDENTIFIED A NEW DISC HERNIATION LOCATED AT THE L2-3, CAUSING LEFT SIDED LUMBAR RADICULOPATHY. ON (B)(6) 2025, THE PATIENT¿S CONDITION HAD REPORTEDLY DETERIORATED TO A LARGE L2-3 DISC EXTRUSION WITH LEFT HIP AND GROIN RADICULOPATHY. A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT THE L2-3 WAS PERFORMED IN (B)(6) 2025, FOLLOWED BY EXTENSIVE REHABILITATION.

  Patient problems: Inadequate Pain Relief; Unspecified Musculoskeletal problem

  MAUDE report 24688193 ↗
• InjuryMar 25, 2026Lack of Effect

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO INADEQUATE PAIN RELIEF SINCE IMPLANTATION. IT WAS NOTED THAT THE PATIENT RECEIVED ADEQUATE RELIEF DURING THE TRIAL PERIOD. TROUBLESHOOTING WAS PERFORMED, INCLUDING REPROGRAMMING, WITHOUT RESOLUTION. AN X-RAY WAS PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE EVOKE SCS SYSTEM WAS EXPLANTED TO RESOLVE THE REPORTED EVENT. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT. FOLLOWING THE EXPLANT PROCEDURE, THE PATIENT REPORTED THAT THEIR CONDITION HAD WORSENED. THE PATIENT DEVELOPED NEW, PROGRESSIVE SPINAL PATHOLOGY. AN X-RAY OBTAINED ON (B)(6) 2025, IDENTIFIED A NEW DISC HERNIATION LOCATED AT THE L2-3, CAUSING LEFT SIDED LUMBAR RADICULOPATHY. ON (B)(6) 2025, THE PATIENT¿S CONDITION HAD REPORTEDLY DETERIORATED TO A LARGE L2-3 DISC EXTRUSION WITH LEFT HIP AND GROIN RADICULOPATHY. A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT THE L2-3 WAS PERFORMED IN (B)(6) 2025, FOLLOWED BY EXTENSIVE REHABILITATION.

  Patient problems: Inadequate Pain Relief; Unspecified Musculoskeletal problem

  MAUDE report 24688188 ↗
• InjuryMar 19, 2026Patient-Device Incompatibility

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND ANCHOR IMPLANT SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED TO RESOLVE THE REPORTED EVENT. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: Implant Pain

  MAUDE report 24639727 ↗
• InjuryMar 19, 2026Patient-Device Incompatibility

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND ANCHOR IMPLANT SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED TO RESOLVE THE REPORTED EVENT. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: Implant Pain

  MAUDE report 24639725 ↗
• InjuryFeb 27, 2026Inappropriate/Inadequate Shock/Stimulation; Patient-Device Incompatibility; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED MIGRATION OF THE EVOKE CLOSED LOOP STIMULATOR (CLS) ALONG WITH PAIN AT THE CLS IMPLANT SITE. THE PATIENT ADDITIONALLY REPORTED INADEQUATE PAIN RELIEF. THE PHYSICIAN¿S EVALUATION AND X-RAY IMAGING IDENTIFIED ONE LEAD WAS POSITIONED TOO LATERAL, WHICH CONTRIBUTED TO THE INADEQUATE PAIN RELIEF. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE CLS AND LEAD AND RESOLVE THE REPORTED EVENT.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 24470525 ↗
• InjuryFeb 27, 2026Inappropriate/Inadequate Shock/Stimulation; Patient-Device Incompatibility; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED MIGRATION OF THE EVOKE CLOSED LOOP STIMULATOR (CLS) ALONG WITH PAIN AT THE CLS IMPLANT SITE. THE PATIENT ADDITIONALLY REPORTED INADEQUATE PAIN RELIEF. THE PHYSICIAN¿S EVALUATION AND X-RAY IMAGING IDENTIFIED ONE LEAD WAS POSITIONED TOO LATERAL, WHICH CONTRIBUTED TO THE INADEQUATE PAIN RELIEF. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE CLS AND LEAD AND RESOLVE THE REPORTED EVENT.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 24470523 ↗
• DeathFeb 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SALUDA REPRESENTATIVE WAS NOTIFIED BY A STUDY COORDINATOR THAT THE PATIENT HAD PASSED AWAY. THE STUDY COORDINATOR REPORTED THAT, UPON ATTEMPTING TO CONTACT THE PATIENT TO SCHEDULE THEIR 6-MONTH FOLLOW-UP VISIT, THEY WERE INFORMED OF THE PATIENT¿S DEATH. ADDITIONAL DETAILS REGARDING THE EVENT HAVE NOT BEEN PROVIDED TO SALUDA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246669 ↗
• DeathFeb 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SALUDA REPRESENTATIVE WAS NOTIFIED BY A STUDY COORDINATOR THAT THE PATIENT HAD PASSED AWAY. THE STUDY COORDINATOR REPORTED THAT, UPON ATTEMPTING TO CONTACT THE PATIENT TO SCHEDULE THEIR 6-MONTH FOLLOW-UP VISIT, THEY WERE INFORMED OF THE PATIENT¿S DEATH. ADDITIONAL DETAILS REGARDING THE EVENT HAVE NOT BEEN PROVIDED TO SALUDA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246668 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT. THE PATIENT REPORTED THAT THEIR PAIN WHICH WAS BEING TREATED BY THE EVOKE SCS HAD BEEN RESOLVED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680511 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT. THE PATIENT REPORTED THAT THEIR PAIN WHICH WAS BEING TREATED BY THE EVOKE SCS HAD BEEN RESOLVED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680510 ↗
• InjuryNov 21, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. A REVISION PROCEDURE WAS PERFORMED AND THE EVOKE CLOSED LOOP STIMULATOR (CLS) WAS REPLACED AND THERAPY RESTORED. THE PATIENT REPORTED FALLING MULTIPLE TIMES PRIOR TO THE REPORTED EVENT. THE EVOKE SCS SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23615836 ↗
• InjuryNov 21, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. A REVISION PROCEDURE WAS PERFORMED AND THE EVOKE CLOSED LOOP STIMULATOR (CLS) WAS REPLACED AND THERAPY RESTORED. THE PATIENT REPORTED FALLING MULTIPLE TIMES PRIOR TO THE REPORTED EVENT. THE EVOKE SCS SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23615736 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO AN INABILITY TO TOLERATE STIMULATION AT LEVELS SUFFICIENT TO ACHIEVE ADEQUATE PAIN RELIEF. AN X-RAY WAS PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED SATISFACTORY PAIN RELIEF DURING THEIR TRIAL PERIOD AND FOLLOWING EVOKE SCS SYSTEM IMPLANTATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23008994 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO AN INABILITY TO TOLERATE STIMULATION AT LEVELS SUFFICIENT TO ACHIEVE ADEQUATE PAIN RELIEF. AN X-RAY WAS PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED SATISFACTORY PAIN RELIEF DURING THEIR TRIAL PERIOD AND FOLLOWING EVOKE SCS SYSTEM IMPLANTATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23008772 ↗