Invisalign Go 9014Recalls & reported problems
Align Technology, Inc. · Sequential Aligner · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816063020424), received between Jul 7, 2022 and May 27, 2026 — classified as 7 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
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Tooth Loss6
- Tooth Fracture2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS OF UPPER RIGHT SECOND TEMPORARY MOLAR .THE PATIENT REPORTED VISITING A DENTAL SPECIALIST AND REQUIRED MEDICAL INTERVENTION IN THE FORM OF IMPLANT SURGERY. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT IS CONTINUING TREATMENT WITH THE INVISALIGN SYSTEM AND IS CURRENTLY ASYMPTOMATIC.
Patient problems: Tooth Loss
MAUDE report 25298881 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THE SYMPTOM OF TOOTH EXTRACTION OF LR6; HOWEVER, REVIEW OF PATIENT RECORDS SHOWS THAT THE EXTRACTED TOOTH CORRESPONDS TO LL6. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE CLINICAL PROCEDURE OR MEDICATIONS THAT MAY HAVE BEEN PRESCRIBED. IT IS UNKNOWN IF THE PATIENT REQUIRED ADDITIONAL MEDICAL INTERVENTION BEYOND THE EXTRACTION TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE TREATMENT WAS DISCONTINUED OR IF THE PATIENT IS STILL USING THE ALIGNERS, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.
Patient problems: Tooth Loss
MAUDE report 24250513 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATED PATIENT REPORTED THAT HAD AN UNEXPECTED EXTRACTION (TOOTH 2.1). THE PATIENT DIDN'T NEED ANY MEDICAL INTERVENTION, AND MEDICATIONS WERE NOT PRESCRIBED FOR THIS PATIENT
Patient problems: Tooth Loss
MAUDE report 23301693 ↗InjuryJan 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT DIRECTLY REPORTED THE FOLLOWING: THE PATIENT REPORTED SYMPTOMS OF BROKEN LOWER FRONT TOOTH, BROKEN CROWN ON LOWER FRONT TOOTH, AND REQUIRED TOOTH EXTRACTION AND IMPLANT. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT REQUIRING ANY PRESCRIPTION MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS ON (B)(6) 2023; HOWEVER, NO PROGRESS HAS BEEN REPORTED TO THE DENTAL OFFICE YET.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 18610457 ↗InjuryMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED THE EXTRACTION OF UR#7. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Loss
MAUDE report 17007854 ↗InjuryMay 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED FRACTURE OF TOOTH #29 OFF POST/CORE AND CROWN AT BONE LEVEL AND IT CAME OFF. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 17007845 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED SYMPTOMS OF EXTRACTION OF LOWER ANTERIOR TEETH AND RECESSIONS. THE PATIENT REPORTED REQUIRING MEDICAL INTERVENTION LIKE BONE GRAFTING AND IMPLANT PLACEMENT TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED AMOXICILLIN, NORCO, MOTRIN AND MEDROL DOSE PACK TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2022 AND THE PATIENT IS CURRENTLY GETTING BETTER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14952420 ↗
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- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
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- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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