Cefaly® CEFALY DUAL EnhancedRecalls & reported problems
Cefaly Technology SPRL · Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL Enhanced is indicated to be used for: The acute treatment of migraine with or without aura in patients 18 years of age or older. The preventative treatment of episodic migraine in patients 18 years of age or older. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05425018850273), received between Dec 29, 2023 and Apr 8, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. 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
- Insufficient Device Problem Information3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THIS DOCUMENT IS A PRELIMINARY REPORT BASED ON THE INFORMATION CURRENTLY AVAILABLE, PREPARED WITH CAREFUL CONSIDERATION. AT THIS TIME, THERE IS NO EVIDENCE INDICATING THAT THE ISSUE IS DUE TO A MALFUNCTION OF THE CEFALY PRODUCT. THE DEVICE HAS BEEN RETURNED BY THE CUSTOMER AND IS NOW ON ITS WAY TO THE FACTORY FOR A THOROUGH INVESTIGATION. A DETAILED UPDATE WILL BE PROVIDED AFTER THE DEVICE HAS BEEN CLOSELY EXAMINED. THE CUSTOMER REPORTED THAT THEY DISCOVERED THE DEVICE WAS MELTED OVERNIGHT WHILE CHARGING . CUSTOMER SAID LAST USED THE DEVICE LAST WEEK OF THE INCIDENT AND AT THAT TIME THE DEVICE WERE FINE.
Patient problems: Insufficient Information
MAUDE report 19061980 ↗MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY DISCOVERED THE DEVICE WAS MELTED OVERNIGHT WHILE CHARGING . CUSTOMER SAID LAST USED THE DEVICE LAST WEEK OF THE INCIDENT AND AT THAT TIME THE DEVICE WERE FINE.
Patient problems: Insufficient Information
MAUDE report 19061975 ↗MalfunctionDec 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THIS DOCUMENT SERVES AS A PRELIMINARY REPORT, COMPILED WITH THE INFORMATION PRESENTLY AVAILABLE AND ADHERING TO THE PRINCIPLE OF CAUTION. CURRENTLY, THERE IS NO EVIDENCE TO SUGGEST THAT THE ISSUE IS ATTRIBUTABLE TO A MALFUNCTION OF THE CEFALY PRODUCT. THE DEVICE IN QUESTION HAS BEEN RETURNED BY THE CUSTOMER AND IS PRESENTLY EN ROUTE TO THE FACTORY FOR IN-DEPTH ANALYSIS. A COMPREHENSIVE UPDATE WILL BE ISSUED FOLLOWING A DETAILED EXAMINATION OF THE DEVICE. AS PER THE INFORMATION PROVIDED BY THE CUSTOMER, THE INCIDENT OCCURRED A FEW WEEKS PRIOR TO THEIR REPORT ON NOVEMBER 28, 2023. HOWEVER, THE CUSTOMER HAS NOT SPECIFY THE EXACT DATE OF THE INCIDENT. CONSEQUENTLY, THE DATE RECORDED IN SECTION B3 IS AN ESTIMATED ONE. THE CUSTOMER REPORTED THAT THEY DISCOVERED THE PLASTIC HOUSING OF THE CEFALY DEVICE PARTIALLY MELTED ON THE CHARGING DOCK DURING THE CHARGING PROCESS. IT WAS NOTED THAT THE DEVICE HAD BEEN CHARGING FOR APPROXIMATELY FOUR HOURS PRIOR TO THE INCIDENT. IT IS IMPORTANT TO HIGHLIGHT THAT THE CHARGING DOCK WAS CONNECTED TO AN ADAPTER PROVIDED BY THE CLIENT, WHICH IS NOT A PRODUCT OF CEFALY. FURTHERMORE, THE CUSTOMER INDICATED THAT ALTHOUGH THE DEVICE HAD NOT BEEN HEAVILY USED IN
Patient problems: Insufficient Information
MAUDE report 18417424 ↗
Other Stimulator, Nerve, Electrical, Transcutaneous, For Migraine devices
- Cefaly® CEFALY EnhancedCefaly Technology SPRL · Stimulator, Nerve, Electrical, Transcutaneous, For Migraine2 reports
- Cefaly® CEFALY ConnectedCefaly Technology SPRL · Stimulator, Nerve, Electrical, Transcutaneous, For Migraine2 reports
- Cefaly® DualCefaly Technology SPRL · Stimulator, Nerve, Electrical, Transcutaneous, For Migraine1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page