iTero Element 2 202965Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816063020288), received between Sep 15, 2023 and Jun 9, 2024 — classified as 1 injury, 1 malfunction.

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

• InjuryJun 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINANT REPORTED THAT A USER OF AN ITERO ELEMENT 2 SYSTEM EXPERIENCED A MINOR BURN ON HAND WHEN PLUGGING THE CABLE INTO AN OUTLET. THE USER REQUIRED GOING TO THE EMERGENCY ROOM TO ADDRESS THE REPORTED SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 19495255 ↗
• MalfunctionSep 15, 2023Overheating of Device; Sparking; Overheating of Device; Sparking

  THE TREATING DOCTOR REPORTED THE EVENT: WHILE TRYING TO PLUG IN THE POWER CABLE THE USER SENSED A MINOR ELECTRICAL DISCHARGE AND A SPARK FROM THE CABLE WHICH CAUSED A MINOR SKIN BURN. IT HAPPENED AS SHE APPLIED HIGHER FORCE THAN USUAL TO PLUG IT IN. SHE WENT TO GET CHECKED OUT IN THE HOSPITAL BUT WAS NOT HOSPITALIZED. IT IS UNKNOWN IF ANY MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED MINOR INJURY (BURN). THE STAFF MEMBER IS DOING FINE. THERE WAS NO SMOKE PRESENT. THERE WERE NO POWER OUTAGES REPORTED. IT IS UNKNOWN IF A CIRCUIT BREAKER WAS PRESENT.

  Patient problems: Burn(s)

  MAUDE report 17760756 ↗