Skip to content

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other WALKER, MECHANICAL devices

All WALKER, MECHANICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.