DRIVE RTL199Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383000701), received between Jul 29, 2021 and Aug 29, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT SHE "WAS WALKING WITH [ROLLATOR] AND BRAKE CABLES WERE STICKING OUT, WHICH CAUSED HER TO FALL AND HIT HER HEAD." DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Head Injury

  MAUDE report 15311818 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION TO BE TIMELY. WE WILL SUBMIT A FOLLOW-UP ONCE ADDITIONAL DATA IS RECEIVED. THE DEVICE WAS LOANED TO A FRIEND WHO FELL AND BROKE HER HIP. THE OWNER OF THE DEVICE SAID THE DEVICE WAS NOT THE CAUSE OF THE INCIDENT. THE USER SLIPPED AND FELL.

  Patient problems: Fall; Hip Fracture

  MAUDE report 12248541 ↗