Evoke® Charger 3006Recalls & reported problems
Saluda Medical Pty Limited · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09352307000063), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Charge” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Charge1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Failure to Charge; Temperature Problem; Failure to Charge; Temperature Problem
A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THAT THEIR EVOKE CHARGER WAS UNABLE TO BE RECHARGED. DURING ATTEMPTS TO RECHARGE, THE PATIENT REPORTED THAT THE DEVICE BECAME WARM AND INDICATOR LIGHTS ILLUMINATED. THE CHARGER WAS REPLACED TO RESOLVE THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23489986 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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