Evoke® 12C Percutaneous Lead Kit - 60 cm 3008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09352307000087), received between Jan 3, 2024 and Apr 23, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “High impedance” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A DEVICE CHECK PRIOR TO A MAGNETIC RESONANCE IMAGERY (MRI). DISCONNECTED ELECTRODE WAS IDENTIFIED AND THE PATIENT REQUESTED A SYSTEM EXPLANT TO RESTORE MRI COMPATIBILITY. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION ON THE EXPLANT PROCEDURE IS AVAILABLE TO SALUDA. SALUDA REPRESENTATIVES ARE NOT EXPECTED TO BE CONSULTED FURTHER ON THIS EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24965466 ↗
• InjuryApr 23, 2026High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A DEVICE CHECK PRIOR TO A MAGNETIC RESONANCE IMAGERY (MRI). DISCONNECTED ELECTRODE WAS IDENTIFIED AND THE PATIENT REQUESTED A SYSTEM EXPLANT TO RESTORE MRI COMPATIBILITY. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION ON THE EXPLANT PROCEDURE IS AVAILABLE TO SALUDA. SALUDA REPRESENTATIVES ARE NOT EXPECTED TO BE CONSULTED FURTHER ON THIS EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24965462 ↗
• InjuryNov 24, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED IN MEDWATCH: MW5177282, THAT A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE DURING WHICH THE SALUDA LEAD WAS REMOVED BECAUSE IT WAS ASSESSED AS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630357 ↗
• InjuryNov 24, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED IN MEDWATCH: MW5177282, THAT A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE DURING WHICH THE SALUDA LEAD WAS REMOVED BECAUSE IT WAS ASSESSED AS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630356 ↗
• InjuryJan 5, 2024High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THEIR SCS SYSTEM PROGRAM WAS NO LONGER WORKING. IT WAS IDENTIFIED THAT THE SYSTEM HAD DISCONNECTED ELECTRODES. THE PATIENT'S SYSTEM WAS REPROGRAMMED WITH TWO CLOSED-LOOP PROGRAMS. THE PROGRAMS DID NOT PROVIDE THE STABILITY DESIRED, SO THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL IMPEDANCES WERE IN RANGE AND THE PATIENT'S THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18451654 ↗
• InjuryJan 3, 2024High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THEIR SCS SYSTEM PROGRAM WAS NO LONGER WORKING. IT WAS IDENTIFIED THAT THE SYSTEM HAD DISCONNECTED ELECTRODES. THE PATIENT'S SYSTEM WAS REPROGRAMMED WITH TWO CLOSED-LOOP PROGRAMS. THE PROGRAMS DID NOT PROVIDE THE STABILITY DESIRED, SO THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL IMPEDANCES WERE IN RANGE AND THE PATIENT'S THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18440048 ↗