Evoke Active Anchor KitRecalls & reported problems across all models
Saluda Medical Pty Limited · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 2 models of Evoke Active Anchor Kit by Saluda Medical Pty Limited in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2023 and Dec 18, 2025 — classified as 40 injuries.
The most frequently reported specific device problem is “Migration” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Evoke Active Anchor Kit problems
Device problems
- Migration33
- Inappropriate/Inadequate Shock/Stimulation17
- Unintended Movement5
- Adverse Event Without Identified Device or Use Problem4
- High impedance2
Patient problems
- Inadequate Pain Relief25
- No Clinical Signs, Symptoms or Conditions6
- Undesired Nerve Stimulation5
- Impaired Healing2
- Implant Pain2
Evoke Active Anchor Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Evoke® Active Anchor Kit 3043Stimulator, Spinal-Cord, Totally Implanted For Pain Relief30 reports
- Evoke® Active Anchor Kit 3043Stimulator, Spinal-Cord, Totally Implanted For Pain Relief10 reports
Recent Evoke Active Anchor Kit adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Saluda Medical Pty Limited products
All Saluda Medical Pty Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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