Drive RTL10266BKRecalls & reported problems
Drive Devilbiss Healthcare · Nitro Rollator, Black frame,1EA · Class 1
- 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 00822383523927), received between Jul 14, 2023 and Apr 13, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Mechanical Problem1
Patient problems
- Insufficient Information1
- Muscle/Tendon Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Mechanical Problem
PER MDR #2438477-2026-00017: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THAT SHE HAD DIFFICULTY PULLING THE SEAT UPWARDS BY THE HANDLE ON THE SEAT TO FOLD THE ROLLATOR. THEREFORE, THE END USER PULLED UP WITH A QUICK, SHARP MOVEMENT THAT RESULTED IN A TORN ROTATOR CUFF THAT WILL REQUIRE PHYSICAL THERAPY AND A CORTISONE INJECTION. 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: Muscle/Tendon Damage
MAUDE report 24859361 ↗InjuryJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN ATTORNEY, WHO STATED "THE END USER SUFFERED INJURIES TO THEIR RIGHT FOOT, REQUIRING A TOE AMPUTATION AS A RESULT OF HIS USE OF THE NITRO EURO STYLE ROLLATOR." DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17330347 ↗
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- Drive RTL10266Drive Devilbiss Healthcare · WALKER, MECHANICAL8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.