Drive RTL10261RDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00822383262772), received between Nov 12, 2019 and Jul 13, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT SHE "STOOD UP FROM [HER] CHAIR, TOOK A STEP WITH [THE ROLLATOR] AND IT BROKE." THE END USER REPORTEDLY FELL, CAUSING A "KNOT ON HER HIP" AND REQUIRED AN AMBULANCE TO ASSIST HER. SHE IS CURRENTLY TAKING PAIN MEDICATION AND RECEIVING PHYSICAL THERAPY. DRIVE REQUESTED THAT THE UNIT BE RETURNED FOR INVESTIGATION, DURING WHICH IT WAS NOTED THAT THE ROLLATOR SHOWED SIGNS OF EXTREME WEAR AND TEAR, AND IT COULD NOT BE DETERMINED WHETHER THE BREAK IN THE LEG OCCURRED AS A RESULT OF AND THE LEG GAVE OUT AFTER EXTENDED USE.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 17320692 ↗
• InjuryFeb 3, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN ATTORNEY, WHO STATED THAT WHILE THE END USER WAS "ATTEMPTING TO SIT ON THE ROLLATOR" TO USE IT AS A CHAIR, "THE BACKREST TUBE OF THE ROLLATOR SUDDENLY DETACHED FROM THE LEFT SIDE OF THE BACKREST," CAUSING [HER] TO FALL BACKWARDS OUT OF THE ROLLATOR" AND HIT HER HEAD ON THE GROUND. SHE WAS HOSPITALIZED FOR APPROXIMATELY A MONTH, AND RELEASED TO HOME HEALTHCARE. 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: Head Injury

  MAUDE report 16294393 ↗
• InjurySep 19, 2022Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT "HE SAT DOWN ON THE ROLLATOR AT HIS DESK AND THE UNIT BROKE CAUSING HIM TO FALL, AGGRAVATING [HIS] PRE-EXISTING BACK CONDITION." THE END USER REPORTED THAT THE INCIDENT CAUSED SEVERE PAIN REQUIRING MEDICATION. THE END USER DID NOT RETURN THE PRODUCT FOR EVALUATION.

  Patient problems: Fall; Pain

  MAUDE report 15445967 ↗
• InjuryJul 21, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO STATED THAT SHE WAS "SITTING ON UNIT, GOT UP AND THE FRONT RIGHT LEG BROKE," CAUSING HER TO FALL "SIDEWAYS AND HIT HEAD ON KITCHEN TABLE, HIT RIGHT SIDE OF HEAD AND START BLEEDING." THE END USER WENT TO THE HOSPITAL AND CONFIRMED THAT SHE DID NOT SUSTAIN A CONCUSSION AND THAT HER CT SCANS WERE NORMAL. SHE RECEIVED 2 STITCHES AND TYLENOL FOR PAIN. THE END USER REPORTED THAT SHE IS "UNABLE" TO RETURN UNIT FOR EVALUATION

  Patient problems: Fall

  MAUDE report 15075611 ↗
• InjuryNov 10, 2021Fracture; Fracture

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL FILE A FOLLOW-UP SUBMISSION WHEN ADDITIONAL DATA BECOMES AVAILABLE. THE ROLLATOR WAS REPORTED 5 YEARS OLD. WHILE IN USE THE LEG OF THE DEVICE SNAPPED CAUSING THE END-USER TO FALL AGGRAVATING AN EXISTING SPINAL INJURY. HE IS IN SEVERE PAIN AND ON PAIN MEDICATION.

  Patient problems: Fall

  MAUDE report 12791821 ↗
• InjuryNov 12, 2019Fracture; Fracture

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. END-USER PURCHASED THE DEVICE A FEW YEARS AGO. HE WAS USING THE UNIT NORMALLY AROUND THE HOUSE. ON THIS OCCASION THE DEVICE FRAME SNAPPED. HE HAD SURGERY ON 9/27 AND RECEIVED 9 SCREWS AND A METAL PLATE IN HIS LEG. HE HAS PHYSICAL THERAPY. HE MUST REMAIN NON WEIGHT BEARING.

  Patient problems: Bone Fracture(s)

  MAUDE report 9312719 ↗