Cefaly® CEFALY EnhancedRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05425018850280), received between Mar 9, 2026 and Mar 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  THIS IS AN INCIDENT HAPPENED IN CANADA. THE SAME MODEL OF DEVICE ARE ON THE US MARKET UNDER FDA 510K CLEARANCE (K212071). THE INITIAL REPORT WAS RECEIVED BY CEFALY ON FEBRUARY 6, 2026. THE CEFALY MEDICAL TEAM REVIEWED THE CASE AND RECOMMENDED DIRECT FOLLOW UP WITH THE PATIENT TO FURTHER ASSESS SYMPTOM SEVERITY AND RELATEDNESS. ATTEMPTS TO CONTACT THE PATIENT ON FEBRUARY 6, 2026, BY PHONE AND EMAIL WERE UNSUCCESSFUL, AND CONTACT INFORMATION WAS PROVIDED THROUGH MEDICAL PERSONNEL. THE PATIENT LATER REQUESTED A PHONE DISCUSSION, WHICH WAS CONDUCTED BY THE CEFALY MEDICAL TEAM ON FEBRUARY 9, 2026, AT 19:30 EST, DURING WHICH THE PATIENT PROVIDED A DETAILED ACCOUNT OF THE EVENTS AS BELOW. THE PATIENT HAS AN APPROXIMATELY 10-YEAR HISTORY OF MIGRAINE, WITH PROGRESSIVE WORSENING PRIOR TO INITIATION OF CEFALY. HE CARRIES A DIAGNOSIS OF CHRONIC MIGRAINE WITHOUT AURA, INTRACTABLE, WITH STATUS MIGRAINOSUS. HE BEGAN USING ETNS (CEFALY) IN (B)(6) 2026, INITIALLY COMPLETING APPROXIMATELY THREE PREVENTIVE SESSIONS, FOLLOWED MORE RECENTLY BY ACUTE THERAPY SESSIONS. HE REPORTED NO BENEFIT FROM PREVENTIVE USE, WHICH IS EXPECTED GIVEN THE DELAYED ONSET OF PREVENTIVE EFFICACY. WITH ACUTE THERAPY, HE REPO

  Patient problems: Burn(s); Localized Skin Lesion

  MAUDE report 24546280 ↗
• InjuryMar 9, 2026Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  THIS IS AN INCIDENT HAPPENED IN CANADA. THE SAME MODEL OF DEVICE ARE ON THE US MARKET UNDER FDA 510K CLEARANCE (K212071 ) THE INITIAL REPORT WAS RECEIVED BY CEFALY ON FEBRUARY 6, 2026. THE CEFALY MEDICAL TEAM REVIEWED THE CASE AND RECOMMENDED DIRECT FOLLOW UP WITH THE PATIENT TO FURTHER ASSESS SYMPTOM SEVERITY AND RELATEDNESS. ATTEMPTS TO CONTACT THE PATIENT ON (B)(6) 2026 BY PHONE AND EMAIL WERE UNSUCCESSFUL, AND CONTACT INFORMATION WAS PROVIDED THROUGH MEDICAL PERSONNEL. THE PATIENT LATER REQUESTED A PHONE DISCUSSION, WHICH WAS CONDUCTED BY THE CEFALY MEDICAL TEAM ON (B)(6) 2026 AT 19:30 EST, DURING WHICH THE PATIENT PROVIDED A DETAILED ACCOUNT OF THE EVENTS AS BELOW. THE PATIENT HAS AN APPROXIMATELY 10-YEAR HISTORY OF MIGRAINE, WITH PROGRESSIVE WORSENING PRIOR TO INITIATION OF CEFALY. HE CARRIES A DIAGNOSIS OF CHRONIC MIGRAINE WITHOUT AURA, INTRACTABLE, WITH STATUS MIGRAINOSUS. HE BEGAN USING ETNS (CEFALY) IN (B)(6) 2026, INITIALLY COMPLETING APPROXIMATELY THREE PREVENTIVE SESSIONS, FOLLOWED MORE RECENTLY BY ACUTE THERAPY SESSIONS. HE REPORTED NO BENEFIT FROM PREVENTIVE USE, WHICH IS EXPECTED GIVEN THE DELAYED ONSET OF PREVENTIVE EFFICACY. WITH ACUTE THERAPY, HE REPORTED TRANSIE

  Patient problems: Burn(s); Localized Skin Lesion

  MAUDE report 24546279 ↗