Invisalign Assist 8534Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816063020080), received between May 25, 2023 and Feb 17, 2026 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF AN UNSPECIFIED EXTRACTION (WHICH APPEARS TO BE TOOTH 4.5 ACCORDING TO ALIGN RECORDS). NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 24369066 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE EXTRACTION OF TOOTH #21 WAS REQUIRED AFTER IT DEVELOPED CLASS III TOOTH MOBILITY WHILE USING THE INVISALIGN PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 21411325 ↗
• InjuryOct 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED TOOTH LOSS (UNKNOWN TOOTH), PAIN AND SWOLLEN GUMS AROUND FRONT TOOTH. THE PATIENT REPORTED VISITING A GENERAL DENTIST TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE INVISALIGN SYSTEM ALIGNERS.

  Patient problems: Tooth Loss

  MAUDE report 17984175 ↗
• InjurySep 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF VERTIGO AFTER STARTING THE INVISALIGN TREATMENT, DEVELOPED PNEUMONIA AND IS VERY SICK. THE PATIENT REPORTED REQUIRING ADMITTANCE TO THE HOSPITAL. IT IS UNKNOWN IF THE PATIENT REQUIRED MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS (DATE UNKNOWN); HOWEVER, NO PROGRESS HAS BEEN REPORTED TO THE DENTAL OFFICE YET.

  Patient problems: Pneumonia; Vertigo

  MAUDE report 17810916 ↗
• InjuryMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF CYSTS, INFECTIONS AND EXTRACTED TOOTH (UNSPECIFIED). IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.

  Patient problems: Cyst(s); Tooth Loss; Unspecified Infection

  MAUDE report 17007862 ↗