Drive 10215RD-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383100654), received between May 26, 2020 and Oct 23, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO STATED THAT THE BRAKE WAS NO LONGER FUNCTIONING. WHEN THE END USER WAS GETTING UP FROM HER BED, SHE GRABBED THE ROLLATOR WHICH SLID FORWARD CAUSING THE END USER TO FALL TO THE FLOOR. THE END USER'S RIGHT SHIN HIT THE BRAKE CAUSING A WOUND. THE WOUND BECAME INFECTED REQUIRING ANTIBIOTICS. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Wound Infection

  MAUDE report 23368358 ↗
• InjuryOct 5, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY THE END USER, WHO STATED THAT "WHILE SITTING AT HER KITCHEN TABLE ON HER ROLLATOR, THE REAR WHEEL BROKE, CAUSING HER TO FALL BACKWARDS ONTO THE UNIT." EMS TRANSPORTED HER TO THE HOSPITAL, WHERE FILMS SHOWED A 20% FRACTURE TO HER T7 VERTEBRAE. DRIVE ATTEMPTED TO RETRIEVE THE PRODUCT FOR INVESTIGATION, BUT THE END USER HAD ALREADY DISCARDED THE UNIT AFTER THE INCIDENT. DRIVE WILL CONTINUE TO MONITOR FOR TRENDS.

  Patient problems: Vertebral Fracture

  MAUDE report 17876713 ↗
• InjuryAug 28, 2020Use of Device Problem; Use of Device Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE WAS NOT RECOVERED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE CONSUMER WAS SITTING ON THE WALKER SWEEPING WITH HIS BROOM WHEN THE WHEEL SNAPPED. HE FELL, HIT HIS HEAD, AND WENT TO THE DOCTOR. HE RECEIVED NO SERIOUS INJURIES. HISTORICAL DATA FOR COMPLAINTS OF THIS ISSUE WERE VERY LIMITED. DEFECT RATE WAS (B)(4) THE UNIT WAS IN USE FOR 2 YEARS WITH NO MAINTENANCE. THE CONSUMER WAS NOT FOLLOWING THE INSTRUCTIONS FOR USE. THE DEVICE IS NOT A TRANSPORT CHAIR. BRAKES SHOULD BE ENGAGED WHILE SEATED WITH NO MOTION PERMITTED.

  Patient problems: Fall

  MAUDE report 10466094 ↗
• InjuryMay 26, 2020Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. END-USER WAS SITTING ON THE DEVICE WHEN THE FRONT WHEEL OF THE ROLLATOR GAVE OUT. END-USER FELL. HE FELL AND HIT HIS HEAD ON A CONCRETE POST. RETURN ORDER REQUESTED FOR DEVICE TO FACILITATE EVALUATION.

  Patient problems: Fall

  MAUDE report 10090279 ↗