Nerivio FGD000075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017578026), received between Jun 29, 2022 and Sep 9, 2022 — classified as 2 injuries.

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.

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.

• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER LEFT A REVIEW ON NERIVIO WEBSITE. THE REVIEW WAS "INITIALLY, NERIVIO HELPED. AFTER MY 5TH USE, I DEVELOPED A LOUD RINGING IN MY EARS, INTENSE VERTIGO AND NAUSEA, AND DISORIENTATION. IT HAS TAKEN WEEKS TO GET MY BALANCE BACK. I WOULD NOT RECOMMEND IT TO AN Y ONE NOR WILL I EVER USE IT AGAIN." NERIVIO CUSTOMER SUPPORT TRY TO CONTACT THE USER SEVERAL TIMES AND WAS ABLE TO REACH THE USER ON (B)(6) 2022, AND ASKED FOR ADDITIONAL INFORMATION REGARDING THE EVENT. THE USER GAVE THE FOLLOWING INFORMATION: THIS EVENT TOOK PLACE ON (B)(6) 2022, IN THE EVENING. THE USER WAS ON VACATION IN THE (B)(6) WHEN THE FIRST SIGNS OF A MIGRAINE CAME ON. WHEN THE FIRST SIGNS OF A MIGRAINE CAME ON, THE USER WAS ABLE TO START TREATING WITHIN THE HOUR OF ONSET. THE USER SAYS THAT SHE HAS BEEN TO THIS REGION MANY TIMES IN THE LAST 35 YEARS, BUT DOES NOT LIVE AT A HIGHER ELEVATION NORMALLY. THE USER STATES THAT AFTER THE TREATMENT (45 MINUTES AT AN INTENSITY OF 20%) SHE GOT A WEIRD FEELING IN HER HEAD AND A LOUD NOISE LIKE A RINGING. ALMOST LIKE THAT OF A BLARING FIRE ENGINE SIREN. USER EXPERIENCED TERRIBLE VERTIGO AND NAUSEA. THE USER EXPERIENCED A LACK OF BALANCE AND HAD DIFFICULTY SAYING WORDS. SHE

  Patient problems: Balance Problems; Nausea; Tinnitus

  MAUDE report 15391410 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERANICA USA WAS NOTIFIED BY THE PATIENT THAT DURING HER PREGNANCY, SHE CONTINUED TO USE THE NERIVIO DEVICE WHEN HAVING MIGRAINES, AFTER CONSULTING WITH A FEW PHYSICIANS. DURING HER PREGNANCY SHE HAD A MISCARRIAGE. THE PATIENT WAS INITIALLY PPROACHED BY THERANICA MARKETING PERSON, WHO ASKED THE PATIENT FOR A DEVICE TESTIMONIAL, FOLLOWING A POSITIVE FEEDBACK POST THE PATIENT PUBLISHED REGARDING THE EFFECT OF THE NERIVIO DEVICE ON HER MIGRAINE. THE PATIENT AGREED TO GIVE A TESTIMONIAL AND WAS TOLD BY THE MARKETING PERSON THAT SHE BE WILL CONTACTED AGAIN TO COORDINATE THE TESTIMONIAL. WHEN THE PATIENT WAS RE-CONTACTED FOR THE TESTIMONIAL, SHE TOLD THE MARKETING PERSON OF HER MISCARRIAGE AND THAT SHE IS NO LONGER FEELS COMFORTABLE TO PROMOTE THE DEVICE. THE PATIENT ASKED TO BE REMOVED FROM THE COMPANY'S MAILING LIST. THE MARKETING PERSON REPORTED THE EVENT TO THE COMPANY ON (B)(6) 2022. FOLLOWING THIS INFORMATION, THE COMPANY SENT AN E-MAIL TO THE PATIENT AND ASKED HER PERMISSION TO CALL HER IN ORDER TO COLLECT ADDITIONAL INFORMATION. THE REQUEST WAS SENT ON (B)(6) 2022. THE PATIENT REPLIED THE FOLLOWING BY MAIL: "THERE ARE MANY REASONS FOR MISCARRIAGE, NAMELY GENETIC VIABILITY OF THE

  Patient problems: Spontaneous Abortion

  MAUDE report 14853148 ↗