Cefaly® CEFALY ConnectedRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05425018850297), received between Apr 3, 2026 and Apr 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionApr 3, 2026Insufficient Device Problem Information

  THIS INCIDENT OCCURRED IN CANADA. THERE IS NO EVIDENCE INDICATING THAT IT MEETS THE CRITERIA FOR A REPORTABLE MEDICAL DEVICE INCIDENT. THE REPORTING IS CONDUCTED BASED ON THE PRECAUTIONARY PRINCIPLE. DATE OF INCIDENT EXACT DATE NOT YET CONFIRMED; THE INCIDENT OCCURRED PRIOR TO (B)(6) 2026. DESCRIPTION OF THE EVENT ACCORDING TO THE CUSTOMER REPORT: THE USER COMPLETED A 20-MINUTE TREATMENT SESSION USING THE DEVICE. NO ABNORMALITIES WERE OBSERVED DURING THE TREATMENT SESSION. APPROXIMATELY 10 MINUTES AFTER COMPLETING THE TREATMENT, THE DEVICE WAS PLACED ON THE CHARGING DOCK. THE DEVICE APPEARED TO BEGIN CHARGING NORMALLY. AFTER APPROXIMATELY 45-60 MINUTES OF CHARGING, THE CUSTOMER REPORTED HEARING A "POP" SOUND ORIGINATING FROM THE DEVICE FOLLOWED BY THE DETECTION OF AN ODOR OF BURNING PLASTIC. DEVICE USE INFORMATION BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER: THE ORIGINAL USB CABLE SUPPLIED WITH THE DEVICE WAS USED.THE DEVICE HAD NOT PREVIOUSLY BECOME WARM OR OVERHEATED DURING CHARGING. THE DEVICE WAS CONNECTED TO THE SAME ELECTRICAL OUTLET NORMALLY USED FOR CHARGING. THE CUSTOMER REPORTED THAT THE ADAPTOR USED WAS THE ORIGINAL ADAPTOR PROVIDED WITH THE DEVICE. HOWEVER, CEFALY

  Patient problems: Insufficient Information

  MAUDE report 24783801 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  THIS INCIDENT OCCURRED IN CANADA. THERE IS NO EVIDENCE INDICATING THAT IT MEETS THE CRITERIA FOR A REPORTABLE MEDICAL DEVICE INCIDENT. THE REPORTING IS CONDUCTED BASED ON THE PRECAUTIONARY PRINCIPLE. DATE OF INCIDENT: EXACT DATE NOT YET CONFIRMED; THE INCIDENT OCCURRED PRIOR TO (B)(6) 2026. DESCRIPTION OF THE EVENT: ACCORDING TO THE CUSTOMER REPORT: THE USER COMPLETED A 20-MINUTE TREATMENT SESSION USING THE DEVICE. NO ABNORMALITIES WERE OBSERVED DURING THE TREATMENT SESSION. APPROXIMATELY 10 MINUTES AFTER COMPLETING THE TREATMENT, THE DEVICE WAS PLACED ON THE CHARGING DOCK. THE DEVICE APPEARED TO BEGIN CHARGING NORMALLY. AFTER APPROXIMATELY 45-60 MINUTES OF CHARGING, THE CUSTOMER REPORTED HEARING A "POP" SOUND ORIGINATING FROM THE DEVICE FOLLOWED BY THE DETECTION OF AN ODOR OF BURNING PLASTIC. DEVICE USE INFORMATION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER: THE ORIGINAL USB CABLE SUPPLIED WITH THE DEVICE WAS USED. THE DEVICE HAD NOT PREVIOUSLY BECOME WARM OR OVERHEATED DURING CHARGING. THE DEVICE WAS CONNECTED TO THE SAME ELECTRICAL OUTLET NORMALLY USED FOR CHARGING. THE CUSTOMER REPORTED THAT THE ADAPTOR USED WAS THE ORIGINAL ADAPTOR PROVIDED WITH THE DEVICE. HOWEVER, CE

  Patient problems: Insufficient Information

  MAUDE report 24783799 ↗