Evoke ® CAP12 Percutaneous Lead Kit - 60 cm 3008Recalls & reported problems
Saluda Medical Pty Limited · Class 3 · Implant
All models of Evoke CAP12 Percutaneous Lead Kit - 60 cm (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09352307001589), received between Apr 16, 2024 and Apr 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “High impedance” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- High impedance1
- Migration1
Patient problems
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2024High impedance; Migration; High impedance; Migration
A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM RUNNING OPEN LOOP PROGRAMS REPORTED TO NO LONGER BE RECEIVING ADEQUATE STIMULATION. THE PATIENT HAD BEEN PROGRAMMED IN OPEN LOOP PREVIOUSLY DUE TO DISCONNECTED ELECTRODES. TROUBLESHOOTING WAS PERFORMED BUT UNSUCCESSFUL. AN X-RAY WAS PERFORMED WHICH REVEALED THE LEADS HAD MIGRATED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED FREQUENT FALLS, NOT RELATED TO SALUDA SCS SYSTEM. A REVISION PROCEDURE WAS PERFORMED, AND THE SYSTEM WAS REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 19122612 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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