Drive RTL10266BK-TRecalls & reported problems
Drive Devilbiss Healthcare · Nitro Rollator,Tall, Black frame,1EA · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383505305), received between Feb 5, 2020 and Jul 11, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Use of Device Problem1
Patient problems
- Fall1
- Head Injury1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT SHE "CAUGHT HER LEFT MIDDLE FINGER IN THE BRAKING MECHANISM. SHE MANAGED TO DISENGAGE HER FINGER HOWEVER IT WAS BLEEDING PROFUSELY ONTO THE FLOOR." THE END USER BANDAGED HER FINGER HERSELF, AND REPORTED THAT HEALING WAS PROGRESSING NORMALLY. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.
Patient problems: Laceration(s)
MAUDE report 14977597 ↗InjuryFeb 5, 2020Fracture; Use of Device Problem; Fracture; Use of Device Problem
DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. THE SEAT BROKER WHILE CROSSING THE STREET. THE USER HIT HIS HEAD AND RECEIVED MEDICAL ATTENTION AND THERAPY. DEVICE IS NOT MEANT TO BE A TRANSPORT DEVICE. HANGTAG NOTES "DO NOT MOVE ROLLATOR WHILE SEATED. THE BRAKES MUST REMAIN LOCKED" WHILE SEATED.
Patient problems: Fall; Head Injury
MAUDE report 9673022 ↗
Other WALKER, MECHANICAL devices
- Drive 10257BL-1Drive Devilbiss Healthcare · WALKER, MECHANICAL13 reports
- Drive R726RDDrive Devilbiss Healthcare · WALKER, MECHANICAL1 death10 reports
- Drive 790Drive Devilbiss Healthcare · WALKER, MECHANICAL10 reports
- DRIVEMEDICAL 795BDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive 10257RD-1Drive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive R728BLDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive R726BKDrive Devilbiss Healthcare · WALKER, MECHANICAL9 reports
- Drive 10215BL-1Drive Devilbiss Healthcare · WALKER, MECHANICAL8 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page