DRIVEMEDICAL RTL10266DTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00822383972497), received between Sep 20, 2021 and Oct 21, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT THE "RIGHT HANDLE SUDDENLY BENT DOWN WHERE THE PLASTIC HANDLE MEETS THE METAL FRAME" AND REPORTED THAT HER MOTHER LOST HER BALANCE AND BROKE HER LEG. THE END USER WAS TAKEN TO THE HOSPITAL AND UNDERWENT A WEEK OF TREATMENT FOR HER INJURIES. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17981882 ↗
• InjuryAug 9, 2023Break; Break

  DRIVE (B)(4) WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER WHO STATED THAT SHE WAS SITTING ON THE ROLLATOR AND BEING PUSHED THROUGH A THRESHOLD WHEN THE "[RIGHT] FRONT WHEEL BUCKLED AND THREW HER OUT OF THE CHAIR" AND SHE REPORTEDLY BROKE HER RIGHT ANKLE. THE END USER WAS TAKEN TO THE HOSPITAL TO TREAT HER BROKEN ANKLE. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17490546 ↗
• MalfunctionJun 28, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY A PROVIDER, WHO STATED THAT "THE FRAME SNAPPED WHILE USING THE ROLLATOR," ALTHOUGH NO SPECIFIC INFORMATION REGARDING THE MECHANISM OF FAILURE OR THE EXACT LOCATION OR NATURE OF THE BROKEN FRAME WAS PROVIDED. THE END USER WAS REPORTEDLY INJURED, BUT THE DETAILS OF THE INJURY WERE NOT PROVIDED. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17216633 ↗
• InjuryOct 4, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S DAUGHTER, WHO REPORTED THAT "ONE OF THE BOLTS ATTACHING THE BACK REST FELL OUT AND MY MOTHER FELL OFF THE BACK, LANDED ON HER BACK AND HIT THE BACK OF HER HEAD ON THE CONCRETE SIDEWALK. LATER WE ADMINISTERED PAIN RELIEF MEDICINE AND PAIN RUB ON HER SKIN OF HER LOWER BACK. SHE WILL BE GETTING AN X-RAY ON HER BACK." THE END USER DECLINED TO RETURN THE PRODUCT FOR EVALUATION.

  Patient problems: Fall; Head Injury

  MAUDE report 15536008 ↗
• InjurySep 20, 2021Sharp Edges; Sharp Edges

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW UP WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE END-USER WALKED INTO THE MOTIONLESS DEVICE ON THE JETWAY. SHE GAUGED HER LEG ABOUT 6 INCHES LONG. AN AMBULANCE CAME TO TAKE HER TO THE ER. THE ER DOCTOR WAS UNABLE TO COMPLETELY SEW UP THE INJURY. HE GAVE HER 4 STITCHES AND INSTRUCTED HER NOT TO GET IT WET. SHE WAS SENT TO A WOUND CARE SPECIALIST WHO ADDED ADDITIONAL STITCHES TO THE WOUND. HE DEFINED THE INJURY AS AN AVULSION LACERATION. ANTIBIOTICS WERE PRESCRIBED TO PREVENT INFECTION.

  Patient problems: Laceration(s)

  MAUDE report 12495609 ↗