Invisalign System - Comprehensive 9000Recalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00816063020189), received between Jul 7, 2022 and Sep 30, 2026 — classified as 239 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 reports).

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 25 most recent of 239 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  The Treating Doctor reported that the patient had symptoms of paralysis/weakness affecting one side of the face, inability to move the tongue, significant difficulty swallowing, inability to open the jaw, difficulty speaking, jaw spasms, and dystonia. The patient reported hospitalization for two days beginning on (b)(6) 2026. The patient indicated taking Akineton (biperiden) and antihistamines to alleviate the reported symptoms. No known pre-existing allergies or medical conditions were reported. No laboratory or clinical tests were performed. The treatment with the Invisalign System was discontinued on (b)(6) 2026 and, at the time of reporting, the patient was improving.

  Patient problems: Facial Paralysis; Muscle Weakness/Atrophy

  MAUDE report 50947201 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  The Treating Doctor reported that the patient had symptoms associated with complications involving tooth UL7, resulting in its extraction. No additional information is available at this time. Attempts to obtain additional information about the event were unsuccessful.

  Patient problems: Tooth Loss

  MAUDE report 50253324 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  The treating doctor reported that the patient had symptoms of root fracture of tooth UR4 resulting in extraction of the tooth that will require a bridge to be placed. No additional information is available at this time. Attempts to obtain additional information about the event were unsuccessful

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 50221103 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tooth Loss

  MAUDE report 50191518 ↗
• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF SEVERE TOOTH INFECTION, TOOTH EXTRACTION (TOOTH 1.7), BUCCAL DECAY ON TOOTH 4.7, AND UPPER AND LOWER ALIGNERS NOT FITTING PROPERLY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Bacterial Infection; Tooth Loss

  MAUDE report 25907765 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TEETH #29 AND #32 EXTRACTED AFTER ORTHODONTIC TREATMENT STARTED.

  Patient problems: Tooth Loss

  MAUDE report 25875591 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF EXTRACTION OF TOOTH 1.7.

  Patient problems: Tooth Loss

  MAUDE report 25853960 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF LOSS OF TOOTH 1.5. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25749100 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF FRACTURE AND LOSS OF ELEMENT 1.5. THE PATIENT REPORTED VISITING A SPECIALIST AND REQUIRED MEDICAL INTERVENTION CONSISTING OF EXTRACTION OF THE AFFECTED TOOTH AND SUBSEQUENT DENTAL IMPLANT PLACEMENT. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED OR TOOK ANY MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE TREATMENT WAS DISCONTINUED OR IF THE PATIENT IS STILL USING THE INVISALIGN SYSTEM, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 25749099 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SYMPTOMS OF INTENSE PAIN IN THE MOUTH AND HEAD, ACUTE PAIN AND EXTREME SENSITIVITY IN THE UPPER RIGHT ARCH, INABILITY TO EAT, INABILITY TO TOUCH TEETH OR CLOSE THE MOUTH, AND PROGRESSIVE INCREASE IN PAIN THROUGHOUT THE RIGHT SIDE OF THE HEAD. THE PATIENT REPORTED VISITING THE EMERGENCY ROOM, A NEUROLOGIST, HEAD OF DENTIST AND GENERAL PRACTITIONER, PAIN MANAGEMENT TEAM AND MAXILLOFACIAL SURGEON AND REQUIRED MEDICAL INTERVENTION, INCLUDING HOSPITALIZATION FOR FIVE DAYS DUE TO UNCONTROLLED PAIN. THE PATIENT INDICATED RECEIVING INTRAVENOUS MORPHINE AND UNSPECIFIED INTRAVENOUS NEUROLOGICAL MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE TREATMENT WAS DISCONTINUED OR IF THE PATIENT IS STILL USING THE INVISALIGN SYSTEM, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Headache; Neuralgia; Pain

  MAUDE report 25595086 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS INVOLVING TEETH LR6 AND LR7. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25444383 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF EXTRACTION OF TEETH 2.4, 2.5, 2.6, AND 2.7. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION RELATED TO THE REPORTED SYMPTOMS.IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED OR TOOK ANY MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOM(S). IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED. IT IS UNKNOWN IF THE TREATMENT WAS DISCONTINUED OR IF THE PATIENT IS STILL USING THE INVISALIGN SYSTEM, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Tooth Loss

  MAUDE report 25394428 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED IMPLANTS FROM TEETH 7-10 (CURRENTLY HEALING CAPS) AND HAD MISSING TOOTH (9). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25374448 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF TOOTH LR6 EXTRACTION/TOOTH LOSS. THE PANORAMIC X-RAY SHOWED LR6 WITH PRIOR ENDODONTIC TREATMENT, ASSOCIATED PERIAPICAL RADIOLUCENT LESIONS ON THE MESIAL AND DISTAL ROOTS, AND THE PRESENCE OF A DENTAL CROWN.

  Patient problems: Tooth Loss

  MAUDE report 25374442 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF EXTRACTION OF TOOTH #3.6. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25355077 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS OF TOOTH 2.1 AND TENDERNESS AT THE EXTRACTION SITE. THE PATIENT REPORTED VISITING AN ORAL SURGEON AND REQUIRED MEDICAL INTERVENTION, A SURGICAL PROCEDURE FOR CURETTAGE OF THE EXTRACTION SITE AND PLACEMENT OF A GRAFT DUE TO CYST FORMATION AT THE APEX AFTER THE EXTRACTION WAS PERFORMED. THE PATIENT INDICATED TAKING OVER-THE-COUNTER PAIN MEDICATIONS, INCLUDING TYLENOL (ACETAMINOPHEN) AND ADVIL (IBUPROFEN), TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING TREATMENT WITH THE INVISALIGN SYSTEM, AND SOME TENDERNESS PERSISTS AT THE EXTRACTION SITE, ALTHOUGH THE PATIENT IS REPORTED TO BE IMPROVING.

  Patient problems: Cyst(s); Tooth Loss

  MAUDE report 25242745 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH FRACTURE, TOOTH MOBILITY, AND TOOTH LOSS INVOLVING TOOTH #29. THE PATIENT INDICATED TAKING IBUPROFEN TO ALLEVIATE THE REPORTED SYMPTOM(S). THE PATIENT IS CONTINUING TREATMENT WITH THE INVISALIGN SYSTEM, AND THE PATIENT'S CURRENT CONDITION WAS REPORTED AS IMPROVING.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 25232013 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF A TOOTH FRACTURE AND TOOTH EXTRACTION OF TOOTH 2.5 RESULTING IN TOOTH LOSS.NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 25123927 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF LOSS OF TEETH LL7 AND LR7. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25094530 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS INVOLVING TOOTH #5. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION RELATED TO THE REPORTED EVENT. 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 REPORTED TO BE DOING WELL.

  Patient problems: Tooth Loss

  MAUDE report 25033295 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF LOSS (TOOTH #27) AND INDICATED THAT THE PATIENT PRESENTED WITH SINUSITIS OF THE LEFT MAXILLARY SINUS INVOLVING THE BONE OF THE ENTIRE AREA OF THE TOOTH LOSS. IT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 25001357 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH LOSS OF TOOTH 4.6, FISTULA FORMATION, AND GRADE I TOOTH MOBILITY. THE PATIENT INDICATED BEING PRESCRIBED CLAVULIN (AMOXICILLIN/CLAVULANIC ACID) TO ALLEVIATE THE REPORTED SYMPTOMS FOLLOWING THE EXTRACTION. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED. THE PATIENT IS CONTINUING TREATMENT WITH THE INVISALIGN SYSTEM AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Fistula; Tooth Loss

  MAUDE report 24952906 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF SIGNIFICANT TEMPOROMANDIBULAR JOINT PAIN AND RIGHT MANDIBULAR CONDYLAR RESORPTION, THE TREATING DOCTOR REPORTED HAVING TO USE ORTHODONTIC BRACES TO REESTABLISH THE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24941190 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF LOSS OF A TOOTH (TREATING DOCTOR SAID TOOTH #24, HOWEVER, IN THE MOST RECENT SCAN SHOWS TOOTH #25). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 24910955 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF LOSS (EXTRACTION) OF TOOTH #14. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.

  Patient problems: Tooth Loss

  MAUDE report 24859378 ↗