Propel ASM-20018Recalls & reported problems

Propel Orthodontics LLC · C-Shaped Vibration Device · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852673007011), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Device problems

Device Operates Differently Than Expected1
Noise, Audible1

Patient problems

Discomfort1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 11, 2017Device Operates Differently Than Expected; Noise, Audible
I HAVE TWO ISSUES TO REPORT REGARDING A MEDICAL DEVICE BY PROPEL ORTHODONTICS. THE DEVICE IS CALLED PROPEL VPRO5. THE FIRST IS THAT IT SEEMS THIS DEVICE IS BEING GIVEN (SOLD) TO PATIENTS BY ORTHODONTISTS FOR AN UNAPPROVED PURPOSE. I READ THAT IT WAS APPROVED BY THE FDA AS "A DEVICE THAT VIBRATES TO ASSIST CLEAR PLASTIC ALIGNERS TO FIT TO A PATIENT'S TEETH." INSTEAD IT WAS GIVEN TO ME (FOR ADDITIONAL COST) BY AN ORTHODONTIST TO ACCELERATE THE MOVEMENT OF TEETH DURING TREATMENT WITH INVISALIGN ALIGNERS. SECONDLY, THIS DEVICE IS HELD IN THE MOUTH BY BITING AND HOLDING. WHEN TURNED ON IT PRODUCES HIGH FREQUENCY VIBRATIONS THAT THE PATIENT FEELS IN THE JAW AND EAR. EVERY TIME I USE THIS DEVICE IT IMMEDIATELY CAUSES IMBALANCE AND I HEAR A LOW PITCHED HUMMING SOUND. THE IMBALANCE IS CERTAINLY RELATED TO VIBRATIONS IN THE FLUID INSIDE THE SEMICIRCULAR CANALS (BALANCE SYSTEM) OF THE INNER EAR. IN ADDITION TO THE OBVIOUS IMBALANCE EFFECTS, THIS DEVICE SHOULD BE EVALUATED FOR EFFECTS ON THE INNER EAR COCHLEAR HEARING SYSTEM WHICH WOULD NOT BE IMMEDIATELY OBVIOUS TO THE PATIENT BUT THIS COULD CAUSE PERMANENT HEARING DAMAGE OVER TIME. THE PRODUCT PACKAGING COMES WITH NO WARNINGS. I FIND IT UNUS
Patient problems: Discomfort
MAUDE report 6793989 ↗

Device details

UDI-DI	`00852673007011`
Brand	Propel
Model	ASM-20018
Company	Propel Orthodontics LLC
Product code	ECR · Setter, Band, Orthodontic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 9, 2022

Device type (GMDN): Orthodontic appliance system, bonded

An assembly of custom-made and preformed devices such as metal bands, archwires, springs, screws, power arms and/or a base plate (framework), designed to be applied to the teeth to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Often referred to as dental braces, it is intended to remain in the oral cavity for the duration of the treatment, and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-use device.

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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