Evoke® Active Anchor Kit 3043 (UDI 09352307001718)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 09352307001718), received between Mar 12, 2024 and Dec 18, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Migration” (26 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF AFTER A MOTOR VEHICLE ACCIDENT. THE IMPLANTED LEADS WERE REPORTED TO HAVE MIGRATED. A REVISION PROCEDURE WAS COMPLETED AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23846018 ↗
• InjuryDec 18, 2025Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF AFTER A MOTOR VEHICLE ACCIDENT. THE IMPLANTED LEADS WERE REPORTED TO HAVE MIGRATED. A REVISION PROCEDURE WAS COMPLETED AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23846000 ↗
• InjuryDec 10, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. AN X-RAY CONFIRMED LEAD MIGRATION. REPROGRAMMING WAS PERFORMED BUT UNABLE TO RESTORE ADEQUATE THERAPY. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23773915 ↗
• InjuryDec 10, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. AN X-RAY CONFIRMED LEAD MIGRATION. REPROGRAMMING WAS PERFORMED BUT UNABLE TO RESTORE ADEQUATE THERAPY. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23773914 ↗
• InjuryOct 31, 2025High impedance; Migration; High impedance; Migration

  WHEN PERFORMING THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM DEVICE CHECK BEFORE MAGNETIC RESONANCE IMAGING (MRI), DISCONNECTED ELECTRODES WERE IDENTIFIED ON THE RIGHT LEAD. X-RAY CONFIRMED MIGRATION OF RIGHT LEAD. A REVISION PROCEDURE WAS PERFORMED, AND THE PHYSICIAN ELECTED TO REPLACE THE EVOKE SCS SYSTEM AND RESTORE MRI COMPATIBILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435290 ↗
• InjuryOct 31, 2025High impedance; Migration; High impedance; Migration

  WHEN PERFORMING THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM DEVICE CHECK BEFORE MAGNETIC RESONANCE IMAGING (MRI), DISCONNECTED ELECTRODES WERE IDENTIFIED ON THE RIGHT LEAD. X-RAY CONFIRMED MIGRATION OF RIGHT LEAD. A REVISION PROCEDURE WAS PERFORMED, AND THE PHYSICIAN ELECTED TO REPLACE THE EVOKE SCS SYSTEM AND RESTORE MRI COMPATIBILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435281 ↗
• InjurySep 2, 2025Migration; Migration

  SALUDA REPRESENTATIVES WERE NOTIFIED OF INADEQUATE PAIN RELIEF AND LEAD MIGRATION FOR A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. AN EXPLANT WAS REPORTED TO BE COMPLETED TO RESOLVE THE REPORTED EVENT. SALUDA REPRESENTATIVES WERE INITIALLY NOTIFIED OF THIS EVENT THROUGH A 3RD PARTY AND NO FURTHER INFORMATION HAS BEEN RECEIVED. THE EXPLANT DATE WAS NOT CONFIRMED AND THE EXACT DATE OF EXPLANT UNKNOWN. (B)(6) 2025 IS SELECTED AS AN APPROXIMATE EVENT DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22936914 ↗
• InjurySep 2, 2025Migration; Migration

  SALUDA REPRESENTATIVES WERE NOTIFIED OF INADEQUATE PAIN RELIEF AND LEAD MIGRATION FOR A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. AN EXPLANT WAS REPORTED TO BE COMPLETED TO RESOLVE THE REPORTED EVENT. SALUDA REPRESENTATIVES WERE INITIALLY NOTIFIED OF THIS EVENT THROUGH A 3RD PARTY AND NO FURTHER INFORMATION HAS BEEN RECEIVED. THE EXPLANT DATE WAS NOT CONFIRMED AND THE EXACT DATE OF EXPLANT UNKNOWN. (B)(6) 2025 IS SELECTED AS AN APPROXIMATE EVENT DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22936357 ↗
• InjuryJul 23, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. THE PATIENT REPORTED INCREASING STIMULATION IN THE ABDOMEN AREA AND ONE (1) EVENT OF UNEXPECTED INTERRUPTION OF THERAPY IN CLOSED LOOP. X-RAY IMAGING WAS OBTAINED WHICH CONFIRMED A LEAD MIGRATION. THE PATIENT WAS REPROGRAMMED TO TEMPORARILY RESTORE THERAPY, PENDING A LEAD REVISION TO RESOLVE THE LEAD MIGRATION. A LEAD REVISION PROCEDURE WAS COMPLETED THERAPY RESTORED TO THE PATIENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22579632 ↗
• InjuryApr 11, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INSUFFICIENT PAIN RELIEF.. TROUBLESHOOTING WAS PERFORMED, INCLUDED REPROGRAMMING. X-RAYS SHOW MIGRATION OCCURRED. DURING THE LEAD REVISION, REPOSITIONING WAS NOT AVAILABLE DUE TO SCAR TISSUE, THEREFORE; BOTH LEADS WERE REPLACED RESTORING ADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21827891 ↗
• InjuryApr 11, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INSUFFICIENT PAIN RELIEF. TROUBLESHOOTING WAS PERFORMED, INCLUDED REPROGRAMMING. X-RAYS SHOW MIGRATION OCCURRED. DURING THE LEAD REVISION, REPOSITIONING WAS NOT AVAILABLE DUE TO SCAR TISSUE, THEREFORE; BOTH LEADS WERE REPLACED RESTORING ADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21827890 ↗
• InjuryMar 25, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR STIMULATION AT THE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE RECEIVING THERAPY. AN X-RAY WAS OBTAINED WHICH CONFIRMED LEAD MIGRATION TO THE CLS IMPLANT SITE. A REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21689994 ↗
• InjuryMar 25, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR STIMULATION AT THE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE RECEIVING THERAPY. AN X-RAY WAS OBTAINED WHICH CONFIRMED LEAD MIGRATION TO THE CLS IMPLANT SITE. A REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21689990 ↗
• InjuryFeb 26, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHANGE IN STIMULATION. A LEAD MIGRATION WAS CONFIRMED. THE PATIENT REPORTED A FALL PRIOR TO THE REPORTED EVENT. THE EVOKE SCS SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALLS. A LEAD REVISION WAS COMPLETED AND THERAPY RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469447 ↗
• InjuryFeb 26, 2025Migration; Migration

  A PATIENT WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHANGE IN STIMULATION. A LEAD MIGRATION WAS CONFIRMED. THE PATIENT REPORTED A FALL PRIOR TO THE REPORTED EVENT. THE EVOKE SCS SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALLS. A LEAD REVISION WAS COMPLETED AND THERAPY RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469445 ↗
• InjuryFeb 7, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF. A LEAD MIGRATION WAS CONFIRMED. A LEAD REVISION WAS PERFORMED TO REPLACE THE LEAD AND ANCHOR. THERAPY HAS BEEN RESTORED TO THE PATIENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21332460 ↗
• InjuryFeb 7, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF. A LEAD MIGRATION WAS CONFIRMED. A LEAD REVISION WAS PERFORMED TO REPLACE THE LEAD AND ANCHOR. THERAPY HAS BEEN RESTORED TO THE PATIENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21332459 ↗
• InjuryJan 31, 2025Migration; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN STIMULATION. X-RAY IMAGING WAS OBTAINED WHICH CONFIRMED LEAD MIGRATION. A LEAD REVISION WAS COMPLETED TO RESTORE THERAPY. LEAD INFORMATION: BRAND NAME - EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US), MODEL - 102878, CATALOG - 3008, LOT/BATCH NUMBER - 9016004179.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21285051 ↗
• InjuryJan 31, 2025Migration; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN STIMULATION. X-RAY IMAGING WAS OBTAINED WHICH CONFIRMED LEAD MIGRATION. A LEAD REVISION WAS COMPLETED TO RESTORE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21284978 ↗
• InjuryJan 16, 2025Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR LEAD MIGRATION. AN X-RAY WAS OBTAINED AND CONFIRMED MIGRATION OF BOTH LEADS. A REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE ISSUE AND RESTORE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175667 ↗
• InjuryJan 16, 2025Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR LEAD MIGRATION. AN X-RAY WAS OBTAINED AND CONFIRMED MIGRATION OF BOTH LEADS. A REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE ISSUE AND RESTORE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175620 ↗
• InjuryDec 4, 2024Inappropriate/Inadequate Shock/Stimulation; Unintended Movement; Inappropriate/Inadequate Shock/Stimulation; Unintended Movement

  DURING ROUTINE PROGRAMMING, A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED STIMULATION IN THEIR RIGHT UPPER EXTREMITY. AN X-RAY WAS OBTAINED AND CONFIRMED A LEAD MIGRATION. A LEAD REVISION WAS COMPLETED TO RESOLVE THE ISSUE AND RESTORE THERAPY. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT¿S CLOSED LOOP STIMULATOR (CLS) WAS REPLACED AND A NEWER DEVICE MODEL IMPLANTED. THE REASON FOR THE DEVICE REPLACEMENT WAS NOT DISCLOSED TO SALUDA.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 20846677 ↗
• InjuryDec 4, 2024Inappropriate/Inadequate Shock/Stimulation; Unintended Movement; Inappropriate/Inadequate Shock/Stimulation; Unintended Movement

  DURING ROUTINE PROGRAMMING, A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED STIMULATION IN THEIR RIGHT UPPER EXTREMITY. AN X-RAY WAS OBTAINED AND CONFIRMED A LEAD MIGRATION. A LEAD REVISION WAS COMPLETED TO RESOLVE THE ISSUE AND RESTORE THERAPY. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT¿S CLOSED LOOP STIMULATOR (CLS) WAS REPLACED AND A NEWER MODEL IMPLANTED. THE REASON FOR THE DEVICE REPLACEMENT WAS NOT DISCLOSED TO SALUDA.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 20845816 ↗
• InjuryOct 31, 2024Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE DECREASE IN PAIN RELIEF AND UNINTENDED STIMULATION. THE PATIENT REPORTED THAT THEY HAD BEEN INVOLVED IN PHYSICAL ACTIVITIES WHICH INVOLVED, INCLUDING LIFTING HEAVY OBJECTS. AN X-RAY WAS OBTAINED WHICH REVEALED MIGRATION OF THE RIGHT LEAD. A REVISION WAS PERFORMED AND THE EVOKE SCS SYSTEM WAS REPLACED. THERAPY HAS BEEN RESTORED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20584907 ↗
• InjuryOct 31, 2024Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED DECREASE IN PAIN RELIEF AND UNINTENDED STIMULATION. THE PATIENT REPORTED THAT THEY HAD BEEN INVOLVED IN PHYSICAL ACTIVITIES, INCLUDING LIFTING HEAVY OBJECTS. AN X-RAY WAS OBTAINED WHICH REVEALED MIGRATION OF THE RIGHT LEAD. A REVISION WAS PERFORMED AND THE EVOKE SCS SYSTEM WAS REPLACED. THERAPY HAS BEEN RESTORED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20584906 ↗