Invisalign First-Comprehensive 9007Recalls & reported problems
Align Technology, Inc. · Sequential Aligner · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816063020264), received between Jul 26, 2022 and Jul 27, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Angioedema1
- Dyspnea1
- Nausea1
- Swelling/ Edema1
- Tooth Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
The Treating Doctor reported that the patient had symptoms of a large infection in tooth 7.5 resulting in extraction of the tooth, and reported agenesis of tooth 3.5.
Patient problems: Tooth Loss
MAUDE report 50033919 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF BREATHING DISCOMFORT AFTER INADVERTENTLY SWALLOWING A FRAGMENT OF A FRACTURED ALIGNER WHILE USING THE INVISALIGN SYSTEM (SECONDARY ORDER, STAGE 34). THE PATIENT REPORTED VISITING THE HOSPITAL AND REQUIRED MEDICAL INTERVENTION, INCLUDING HOSPITALIZATION, WHERE THE PATIENT WAS EVALUATED AND STABILIZED, AND IS CURRENTLY IN GOOD CONDITION WITH NO ONGOING COMPLICATIONS. THE PATIENT INDICATED BEING PRESCRIBED TAB IBASTIN (EBASTINE) TO ALLEVIATE THE REPORTED SYMPTOMS AND THE PATIENT IS CURRENTLY ASYMPTOMATIC.
Patient problems: Dyspnea
MAUDE report 25444444 ↗InjuryJul 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED SYMPTOMS OF BLUSH, NAUSEA, DIFFICULTY BREATHING AND SWOLLEN EYE. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED EYE DROPS TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATING DOCTOR REPORTED THAT THE PATIENT PRESENTED EVIDENCE OF HEREDITARY ANGIOEDEMA (HAE). THE TREATMENT WAS DISCONTINUED ON (B)(6) 2022 AND THE PATIENT IS CURRENTLY GETTING BETTER.
Patient problems: Angioedema; Nausea; Swelling/ Edema
MAUDE report 15108624 ↗
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- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.