drive RTL10266TWHLRecalls & reported problems
Drive Devilbiss Healthcare · Rollators 3-Wheel Product Description Nitro 3-Wheel Rollator, Red, 1/EA · 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 00822383006314), received between Jul 7, 2022 and Sep 6, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
- Device Damaged Prior to Use1
Patient problems
- Easy Bruising1
- Fall1
- 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.
InjurySep 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A ROLLATOR FROM AN END USER'S DAUGHTER, WHO REPORTED THAT "THE LOCKING MECHANISM IS NOT WORKING WHICH CAUSES IT TO COLLAPSE RESULTING IN FALLS. THERE WAS A RED HANDLE WHICH HAS FALLEN OFF." THE END USER SUSTAINED "SKIN TEARS," ONE OF WHICH REQUIRED "MULTIPLE VISITS TO WOUND CARE." DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT.
Patient problems: Laceration(s)
MAUDE report 15364484 ↗InjuryJul 7, 2022Device Damaged Prior to Use; Insufficient Device Problem Information; Device Damaged Prior to Use; Insufficient Device Problem Information
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER REPORTED THAT "THE FRONT WHEEL OF HIS UNIT IS NOT STRAIGHT AND CAUSES THE UNIT TO TIP OVER FROM TIME TO TIME," BUT THAT HE DID NOT NOTICE ANY PROBLEM WITH THE WHEEL OUT OF THE BOX. DESPITE NOTICING THE DEFECT, THE END USER CONTINUED TO USE THE DEVICE AND REPORTED RECEIVING BRUISES, CUTS AND A HEAD INJURY, RESULTING IN AN EMERGENCY ROOM VISIT WITH AN X-RAY AND CT-SCAN OF THE CERVICAL SPINE. DRIVE ATTEMPTED BUT WAS NOT ABLE TO RETRIEVE THE UNIT FOR EVALUATION.
Patient problems: Easy Bruising; Fall
MAUDE report 14945907 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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