Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008 (UDI 09352307001640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 09352307001640), received between Dec 13, 2023 and Sep 22, 2026 — classified as 138 injuries.

The most frequently reported specific device problem is “Migration” (39 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Inadequate Pain Relief

  MAUDE report 50861026 ↗
• InjurySep 22, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Inadequate Pain Relief

  MAUDE report 50861025 ↗
• InjurySep 10, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A patient previously implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for a change in stimulation. X-rays confirmed lead migration. A lead revision was completed by repositioning both leads.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50718153 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) system was evaluated in the emergency department for weakness, disorientation, mild fever and bladder issues. Anomalies were not identified via Computed Tomography (CT) scan and blood tests. Redness or drainage were not observed at the lead implant site. The patient was hospitalized and antibiotics were administered as a precautionary measure. An infection was detected during an ultrasound scan and the Evoke SCS System was subsequently explanted.The physician indicated that the event may have been triggered by the patient¿s fall and patient¿s poor hygiene may have contributed to the infection.

  Patient problems: Ambulation or Postural Difficulties; Fall; Incontinence; Muscle Weakness/Atrophy; Unspecified Infection

  MAUDE report 50225025 ↗
• InjuryJul 13, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. AN IMPEDANCE CHECK IDENTIFIED MULTIPLE DISCONNECTED ELECTRODES. X-RAYS CONFIRMED NO EVIDENCE OF LEAD MIGRATION. REPROGRAMMING WAS PERFORMED BUT ADEQUATE PAIN RELIEF COULD NOT BE ACHIEVED. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEAD WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25793956 ↗
• InjuryJul 13, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. AN IMPEDANCE CHECK IDENTIFIED MULTIPLE DISCONNECTED ELECTRODES. X-RAYS CONFIRMED NO EVIDENCE OF LEAD MIGRATION. REPROGRAMMING WAS PERFORMED BUT ADEQUATE PAIN RELIEF COULD NOT BE ACHIEVED. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEAD WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25793954 ↗
• InjuryJun 12, 2026High impedance

  WHEN PERFORMING THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM DEVICE CHECK BEFORE MAGNETIC RESONANCE IMAGING (MRI), DISCONNECTED ELECTRODES WERE IDENTIFIED ON ONE (1) LEAD. A REVISION PROCEDURE WAS PERFORMED, AND THE EVOKE LEAD WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488339 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR DELAYED HEALING AND SIGNS OF DEHISCENCE AT THE MIDLINE INCISION SITE. WASHOUT AND DEBRIDEMENT WERE PERFORMED, AND ANTIBIOTICS WERE ADMINISTERED AT THE MIDLINE INCISION SITE.

  Patient problems: Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 25461540 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR DELAYED HEALING AND SIGNS OF DEHISCENCE AT THE MIDLINE INCISION SITE. WASHOUT AND DEBRIDEMENT WERE PERFORMED, AND ANTIBIOTICS WERE ADMINISTERED AT THE MIDLINE INCISION SITE.

  Patient problems: Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 25459375 ↗
• InjuryJun 2, 2026Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT MULTIPLE SPINAL INJECTIONS. FOLLOWING THESE INJECTIONS, THE PATIENT REPORTED SIGNIFICANT PAIN RELIEF AND REQUESTED EXPLANT OF THE EVOKE SCS SYSTEM. THE EXPLANT REQUEST WILL BE EVALUATED BY THE PHYSICIAN. THE PATIENT REPORTED DISCONTINUING USE OF THE SCS THERAPY, STATING THAT THEY BELIEVE THE STIMULATION WAS AFFECTING THEIR HEART. DEVICE EVALUATION CONCLUDED THAT THE PATIENT EXPERIENCED STIMULATION IN THEIR LOWER BACK AND LEGS AND NOT IN THE CHEST AREA.

  Patient problems: Inadequate Pain Relief; Unspecified Heart Problem

  MAUDE report 25358945 ↗
• InjuryJun 2, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN X-RAY IDENTIFIED MIGRATION OF BOTH LEADS. REPROGRAMMING WAS PERFORMED BUT THE THERAPY COULD NOT BE RESTORED. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25358767 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR REDNESS, PAIN, AND FLUID DISCHARGE AT THE LEAD IMPLANT SITE. AN INFECTION WAS SUSPECTED AND THE EVOKE SCS SYSTEM WAS SUBSEQUENTLY EXPLANTED. CULTURE COLLECTED WERE POSITIVE FOR INFECTION, AND ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Impaired Healing; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24884466 ↗
• InjuryApr 15, 2026High 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 IDENTIFIED DISCONNECTED ELECTRODES. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL IN RESTORING ADEQUATE THERAPY. A REVISION PROCEDURE WAS PERFORMED, AND THE LEADS WERE REPLACED TO RESTORE THERAPY AND MRI COMPATIBILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24884426 ↗
• InjuryApr 15, 2026High 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 IDENTIFIED DISCONNECTED ELECTRODES. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL IN RESTORING ADEQUATE THERAPY. A REVISION PROCEDURE WAS PERFORMED, AND THE LEADS WERE REPLACED TO RESTORE THERAPY AND MRI COMPATIBILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24884398 ↗
• InjuryApr 1, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. LEAD MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. REPROGRAMMING WAS UNABLE TO RESTORE ADEQUATE THERAPY. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS WERE REPLACED TO RESTORE THERAPY. IT WAS NOTED THAT NON-SALUDA ANCHORS WERE USED TO SECURE THE MIGRATED LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24756015 ↗
• InjuryApr 1, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. LEAD MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. REPROGRAMMING WAS UNABLE TO RESTORE ADEQUATE THERAPY. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS WERE REPLACED TO RESTORE THERAPY. IT WAS NOTED THAT NON-SALUDA ANCHORS WERE USED TO SECURE THE MIGRATED LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24755765 ↗
• InjuryApr 1, 2026High impedance

  DURING A PRE-MAGNETIC RESONANCE IMAGING (MRI) DEVICE CHECK OF THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, A DISCONNECTED ELECTRODE WAS IDENTIFIED. AS A RESULT, THE PATIENT COULD NOT UNDERGO THE MRI. AT THE PATIENT¿S REQUEST, THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755648 ↗
• InjuryMar 18, 2026High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A ROUTINE DEVICE CHECK PRIOR TO A MAGNETIC RESONANCE IMAGERY (MRI) SCAN FOR AN UNRELATED CONDITION. DISCONNECTED ELECTRODES WERE IDENTIFIED DURING AN IMPEDANCE CHECK. A LEAD REVISION WAS SUBSEQUENTLY PERFORMED TO REPLACE THE LEADS AND RESTORE MRI COMPATIBILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628271 ↗
• InjuryMar 9, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED UNINTENDED STIMULATION IN THEIR RIB REGION. REPROGRAMMING WAS COMPLETED BUT UNABLE TO RESOLVE THE REPORTED EVENT. AN X-RAY WAS OBTAINED AND CONFIRMED MIGRATION OF TWO (2) LEADS. THE EVOKE SCS SYSTEM WAS EXPLANTED TO RESOLVE THE REPORTED EVENT. IT WAS NOTED THAT NON-SALUDA ANCHORS WERE USED TO SECURE THE MIGRATED LEADS.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24547333 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. ANTIBIOTICS WERE ADMINISTERED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24520539 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. ANTIBIOTICS WERE ADMINISTERED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24520453 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  WHILE TRAVELING ABROAD, A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED IN THE EMERGENCY DEPARTMENT FOR A POSSIBLE INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT PROVIDED TO THE SALUDA REPRESENTATIVE.

  Patient problems: Unspecified Infection

  MAUDE report 24454433 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  WHILE TRAVELING ABROAD, A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED IN THE EMERGENCY DEPARTMENT FOR A POSSIBLE INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. ADDITIONAL DETAILS REGARDING THE EVENT WERE NOT PROVIDED TO THE SALUDA REPRESENTATIVE.

  Patient problems: Unspecified Infection

  MAUDE report 24454432 ↗
• InjuryFeb 18, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF AND NOTED THAT THE EVOKE CLOSED LOOP STIMULATOR (CLS) FELT WARM DURING CHARGING. REPROGRAMMING WAS ATTEMPTED BUT COULD NOT RESTORE ADEQUATE THERAPY. LEAD MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. A REVISION PROCEDURE WAS PERFORMED AND THE EVOKE SCS SYSTEM WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24380081 ↗
• InjuryFeb 18, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF AND NOTED THAT THE EVOKE CLOSED LOOP STIMULATOR (CLS) FELT WARM DURING CHARGING. REPROGRAMMING WAS ATTEMPTED BUT COULD NOT RESTORE ADEQUATE THERAPY. LEAD MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. A REVISION PROCEDURE WAS PERFORMED AND THE EVOKE SCS SYSTEM WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24380006 ↗