Evoke CAP12 Percutaneous Lead Kit - 60 cmRecalls & reported problems across all models
Saluda Medical Pty Limited · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 155
- Deaths reported
- 0
- Injuries reported
- 154
- Recalls
- 0
We found 3 models of Evoke CAP12 Percutaneous Lead Kit - 60 cm by Saluda Medical Pty Limited in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between May 30, 2023 and Sep 22, 2026 — classified as 154 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (46 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 CAP12 Percutaneous Lead Kit - 60 cm problems
Device problems
- Adverse Event Without Identified Device or Use Problem60
- Migration46
- High impedance42
- Inappropriate/Inadequate Shock/Stimulation35
- Difficult or Delayed Positioning6
- Defibrillation/Stimulation Problem4
- Patient Device Interaction Problem4
- Positioning Failure4
Patient problems
- Inadequate Pain Relief60
- No Clinical Signs, Symptoms or Conditions22
- Unspecified Infection21
- Cerebrospinal Fluid Leakage13
- Impaired Healing11
- Pain10
- Purulent Discharge7
- Undesired Nerve Stimulation7
Evoke CAP12 Percutaneous Lead Kit - 60 cm models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008Stimulator, Spinal-Cord, Totally Implanted For Pain Relief138 reports
- Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008Stimulator, Spinal-Cord, Totally Implanted For Pain Relief16 reports
- Evoke ® CAP12 Percutaneous Lead Kit - 60 cm 3008Stimulator, Spinal-Cord, Totally Implanted For Pain Relief1 report
Recent Evoke CAP12 Percutaneous Lead Kit - 60 cm adverse event reports
The 15 most recent reports across all models, 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 ↗
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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