Evoke® Closed-Loop Stimulator (CLS) 3002 (UDI 09352307000292)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 09352307000292), received between Jun 5, 2023 and May 13, 2026 — classified as 2 deaths, 54 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 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. OVER-THE-COUNTER PAIN MEDICATIONS DID NOT RESOLVE THE ISSUE. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 25160193 ↗
• InjuryMay 13, 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. OVER-THE-COUNTER PAIN MEDICATIONS DID NOT RESOLVE THE ISSUE. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 25160191 ↗
• InjuryApr 17, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS DIAGNOSED WITH PROSTATE CANCER. THE PATIENT REQUESTED EXPLANT OF THEIR EVOKE SCS SYSTEM TO ACCOMMODATE MAGNETIC RESONANCE IMAGING (MRI). THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE MRI COMPATIBLE AND FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856488 ↗
• InjuryApr 17, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS DIAGNOSED WITH PROSTATE CANCER. THE PATIENT REQUESTED EXPLANT OF THEIR EVOKE SCS SYSTEM TO ACCOMMODATE MAGNETIC RESONANCE IMAGING (MRI). THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE MRI COMPATIBLE AND FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855866 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REQUESTED EXPLANT OF THEIR EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT REPORTED RECEIVING A STEM CELL TREATMENT WHICH HAS RESOLVED THEIR PAIN, WHICH WAS PREVIOUSLY BEING TREATED BY THE SCS THERAPY. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE OPERATING AS INTENDED PRIOR TO EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642052 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REQUESTED EXPLANT OF THEIR EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT REPORTED RECEIVING A STEM CELL TREATMENT WHICH HAS RESOLVED THEIR PAIN, WHICH WAS PREVIOUSLY BEING TREATED BY THE SCS THERAPY. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE OPERATING AS INTENDED PRIOR TO EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642051 ↗
• InjuryFeb 11, 2025Lack of Effect; Lack of Effect

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO INADEQUATE PAIN RELIEF. THE SALUDA REPRESENTATIVE CONFIRMED THAT THE PATIENT HAD BEEN IMPLANTED FOR 14 MONTHS, DURING WHICH TIME THERE WERE MULTIPLE ATTEMPTS TO TROUBLESHOOT AND PROGRAM THE PATIENT¿S DEVICE WITH MINIMAL PAIN RELIEF ACHIEVED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE OPERATING AS INTENDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21360864 ↗
• InjuryFeb 11, 2025Lack of Effect; Lack of Effect

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT DUE TO INADEQUATE PAIN RELIEF. THE SALUDA REPRESENTATIVE CONFIRMED THAT THE PATIENT HAD BEEN IMPLANTED FOR 14 MONTHS, DURING WHICH TIME THERE WERE MULTIPLE ATTEMPTS TO TROUBLESHOOT AND PROGRAM THE PATIENT¿S DEVICE WITH MINIMAL PAIN RELIEF ACHIEVED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE OPERATING AS INTENDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21358961 ↗
• DeathOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A ROUTINE FOLLOW-UP, SALUDA PERSONNEL WAS NOTIFIED BY A PATIENT¿S SPOUSE THAT THE PATIENT DIED. THE CAUSE OF DEATH WAS CONFIRMED TO BE CANCER AND NOT RELATED TO THE PATIENT¿S EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE DATE OF DEATH WAS NOT PROVIDED. SALUDA WAS NOT ABLE TO OBTAIN FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520971 ↗
• DeathOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A ROUTINE FOLLOW-UP, SALUDA PERSONNEL WAS NOTIFIED BY A PATIENT¿S SPOUSE THAT THE PATIENT DIED. THE CAUSE OF DEATH WAS CONFIRMED TO BE CANCER AND NOT RELATED TO THE PATIENT¿S EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE DATE OF DEATH WAS NOT PROVIDED. SALUDA WAS NOT ABLE TO OBTAIN FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520967 ↗
• InjuryOct 22, 2024Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHARGING ISSUE AND DISCOMFORT AT THE IMPLANTATION SITE OF THEIR EVOKE CLOSED LOOP STIMULATOR (CLS). THESE WERE ATTRIBUTED TO MOVEMENT OF THE CLS DUE TO THE SIZE OF THE PATIENT¿S CLS POCKET. THE PATIENT REPORTED THAT THEIR PRIOR PAIN CONDITION HAD IMPROVED AND THE EVOKE SCS SYSTEM HAD NOT BEEN USED FOR SEVERAL WEEKS. AT THE PATIENT¿S REQUEST, THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 20502009 ↗
• InjuryOct 20, 2024Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHARGING ISSUE AND DISCOMFORT AT THE IMPLANTATION SITE OF THEIR EVOKE CLOSED LOOP STIMULATOR (CLS). THESE WERE ATTRIBUTED TO MOVEMENT OF THE CLS DUE TO THE SIZE OF THE PATIENT¿S CLS POCKET. THE PATIENT REPORTED THAT THEIR PRIOR PAIN CONDITION HAD IMPROVED AND THE EVOKE SCS SYSTEM HAD NOT BEEN USED FOR SEVERAL WEEKS. AT THE PATIENT¿S REQUEST, THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 20490251 ↗
• InjuryOct 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE IMPLANTATION SITE OF THEIR EVOKE CLOSED LOOP STIMULATOR (CLS). THE EVOKE SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE EXPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 20436467 ↗
• InjuryOct 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE IMPLANTATION SITE OF THEIR EVOKE CLOSED LOOP STIMULATOR (CLS). THE EVOKE SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE EXPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 20436466 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR THEIR IMPLANTATION SITE NOT CLOSING AS EXPECTED. THE PHYSICIAN ATTRIBUTED THIS TO THE SUTURING TECHNIQUE. A REVISION WAS PERFORMED AND THE PATIENT THERAPY RESTORED.

  Patient problems: Impaired Healing

  MAUDE report 20429417 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR THEIR IMPLANTATION SITE NOT CLOSING AS EXPECTED. THE PHYSICIAN ATTRIBUTED THIS TO THE SUTURING TECHNIQUE. A REVISION WAS PERFORMED AND THE PATIENT THERAPY RESTORED.

  Patient problems: Impaired Healing

  MAUDE report 20429409 ↗
• InjurySep 20, 2024Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation; Biocompatibility; Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation; Biocompatibility

  A PATIENT WAS IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM AND HAD ADEQUATE PAIN COVERAGE. FOURTEEN MONTHS LATER, THE PATIENT UNDERWENT AN UNRELATED LUMBAR SPINAL FUSION SURGERY WITH HARDWARE IMPLANTED. FOLLOWING THE PROCEDURE THE PATIENT REPORTED INADEQUATE PAIN RELIEF. DURING RE-PROGRAMMING, THE PATIENT REPORTED PAIN AND DISCONNECTED ELECTRODES WERE IDENTIFIED. THE LEAD WAS DAMAGED BY THE HARDWARE PLACED DURING THE PREVIOUS SURGERY. THE SYSTEM WAS REVISED WHICH RESOLVED THE ISSUE.

  Patient problems: Device Overstimulation of Tissue; Inadequate Pain Relief

  MAUDE report 20267988 ↗
• InjurySep 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED EXPERIENCING DISCOMFORT AT THEIR IMPLANT SITE OF EVOKE CLOSED LOOP STIMULATOR (CLS). AS A RESULT, THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 20131609 ↗
• InjuryJun 14, 2024Adverse 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 WAS REPORTED TO HAVE AN INFECTION WHICH WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19539118 ↗
• InjuryJun 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED EXPERIENCING DIFFICULTIES USING THE EXTERNAL COMPONENTS, EVOKE PATIENT CONTROLLER (EPC) AND EVOKE CHARGER KIT. IT WAS REPORTED THAT FOR THE EPC AND THE CHARGER TO CONNECT, THE PATIENT HAD TO PLACE THE DEVICE BEHIND THEIR BACK, WHICH WAS STRAINING THEIR SHOULDER. IT WAS REPORTED THAT A SEPARATE PLANNED PROCEDURE WAS EXPECTED TO RESOLVE THEIR PAIN AND THEREFORE THE PATIENT'S SCS SYSTEM WAS EXPLANTED.

  Patient problems: Limb Pain

  MAUDE report 19473413 ↗
• InjuryMay 26, 2024Adverse 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 EXPERIENCED IMPAIRED WOUND HEALING AT THEIR IMPLANT SITE AND WAS GIVEN AN ANTIBIOTIC OINTMENT. APPROXIMATELY A MONTH LATER, THE IMPLANT SITE SHOWED WORSENING SIGNS OF INFECTION. ORAL ANTIBIOTICS WERE UNSUCCESSFUL, SO THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 19398940 ↗
• InjuryMay 8, 2024Adverse 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 REPORTED EXPERIENCING A FEVER AND FLUID DISCHARGE FROM THEIR INCISION SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO RESOLVE THE REPORTED SYMPTOMS WHICH WAS UNSUCCESSFUL. THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Fever; Fluid Discharge; Unspecified Infection

  MAUDE report 19268671 ↗
• InjuryApr 30, 2024Adverse 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 REPORTED PAIN AT THE IMPLANT SITE. PROGRAMMING AND AN X-RAY DETERMINED THAT COVERAGE HAD NOT CHANGED, AND THE CAUSE OF THE DISCOMFORT WAS NOT IDENTIFIED. THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 19218369 ↗
• InjuryApr 26, 2024Adverse 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 REPORTED PAIN AT THE IMPLANT SITE. PROGRAMMING AND AN X-RAY DETERMINED THAT COVERAGE HAD NOT CHANGED, AND THE CAUSE OF THE DISCOMFORT WAS NOT IDENTIFIED. THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 19197171 ↗
• InjuryApr 10, 2024Adverse 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 WAS NOT RECEIVING ADEQUATE PAIN RELIEF AND THEREFORE WAS NOT USING THEIR SCS SYSTEM. THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19084472 ↗