Cefaly® DualRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05425018850259), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Product Quality Problem” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Product Quality Problem

  I PURCHASED A CEFALY DUAL MEDICAL DEVICE FOR MIGRAINE SUFFERS FOR MY (B)(6) YEAR OLD NIECE ON (B)(6) 2022. SHE USED IT FOR ABOUT 2 MONTHS, 4 OR 5 TIMES A WEEK. SHE STARTED HAVING OLFACTORY HALLUCINATIONS OF CIGARETTE SMOKE OR BURNING ELECTRICAL WIRING. ON OR ABOUT (B)(6) 2021, I CONTACTED CEFALY TECHNOLOGY CUSTOMER SERVICE TO SEE IF THERE WAS ANY CORRELATION TO THE USE ON THE CEFALY DEVICE AND THESE OLFACTORY HALLUCINATIONS. THE NEXT DAY, A CUSTOMER SERVICE REPRESENTATIVE CONTACTED MY NIECE AND TOLD HER TO DISCONTINUE USING IT, AS THERE HAVE BEEN OTHER REPORTS INVOLVING OLFACTORY HALLUCINATIONS. THIS DEVICE IS ADVERTISED AS THE ONLY FDA APPROVED DEVICE FOR TREATMENT OF MIGRAINES. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12835688 ↗