Drive 10257RD-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822383260204), received between Aug 20, 2019 and Apr 22, 2026 — classified as 9 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE END USER WHO REPORTED THAT THE ROLLATOR'S FRAME SNAPPED IN HALF DURING USE, CAUSING HER TO FALL. AS A RESULT OF THE FALL, THE END USER SUSTAINED A BROKEN TOE. THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THE BROKEN TOE. THE DEVICE WAS DISCARDED BY THE END USER AND IS UNAVAILABLE FOR INSPECTION OR FURTHER EVALUATION. 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: Bone Fracture(s)

  MAUDE report 24955062 ↗
• InjuryOct 29, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S DAUGHTER. ACCORDING TO THE REPORT, THE END USER WAS ATTEMPTING TO LIFT THE ROLLATOR OVER A DOORWAY THRESHOLD WHEN ONE OF THE WHEELS DETACHED FROM THE DEVICE. AS A RESULT, THE END USER LOST THEIR BALANCE AND GRABBED ONTO A NEARBY DOOR HANDLE, WHICH CAUSED A JOLT TO THEIR BACK. THE END USER SUSTAINED TWO COMPRESSION FRACTURES OF THE VERTEBRAE. DUE TO THE END USER'S ADVANCED AGE AND PRE-EXISTING HEALTH CONDITIONS, SURGICAL INTERVENTION WAS NOT CONSIDERED AN OPTION. THE END USER'S DAUGHTER SUBSEQUENTLY DISCARDED THE DEVICE, AND IT IS NO LONGER AVAILABLE FOR EVALUATION. 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: Vertebral Fracture

  MAUDE report 23417020 ↗
• InjuryJul 26, 2023Degraded; Degraded

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT THE "FRONT RIGHT WHEEL EXPLODED." THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE SPECIFIC NATURE OF THE DEFECT. THE END USER REPORTEDLY FELL AND EXPERIENCED SOME PAIN AND SWELLING IN HIS ELBOW, FOR WHICH HE TREATED IN AN EMERGENCY ROOM APPROXIMATELY ONE WEEK LATER. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Swelling/ Edema

  MAUDE report 17398236 ↗
• InjuryApr 19, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S MOTHER, WHO STATED THAT THE "SEAT SNAPPED OFF," CAUSING THE END USER TO FALL AND SUSTAIN BRUISING TO HER BACK AND LEGS." THE REPORTER DID NOT PROVIDE ANY FURTHER INFORMATION ABOUT HOW THE ROLLATOR WAS BEING USED AT THE TIME OF THE INCIDENT. THE END USER WAS REPORTEDLY TAKEN TO THE HOSPITAL BY AMBULANCE TO TREAT HER INJURIES. 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: Bruise/Contusion; Fall

  MAUDE report 16770828 ↗
• InjuryJan 26, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY A LAWYER, WHO STATED THAT THE END USER "WENT TO SIT ON THE UNIT" AND "THE SEAT BROKE," REPORTEDLY CAUSING HER TO FALL "TO THE FLOOR AND HIT HER BOTTOM," RESULTING IN A FRACTURED PELVIS. 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: Bone Fracture(s); Fall

  MAUDE report 16248705 ↗
• InjurySep 3, 2021Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETRIEVED FOR EVALUATION. WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL DATA BECOMES AVAILABLE. THE BRAKES DID NOT ENGAGE FULLY. THE USER SAT DOWN AND THE DEVICE ROLLED. SHE FELL AND BROKE HER CLAVICLE BONE AND RECEIVED SOME BRUISES ON HER HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12424407 ↗
• InjuryOct 27, 2020Off-Label Use; Off-Label Use

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICHI IA A ROLLATOR. THE UNIT WAS TAKEN AND CANNOT BE RETRIEVED FOR EVALUATION. CARETAKER USED THE ROLLATOR AS A TRANSPORT CHAIR. END-USER'S LEG WAS CUT BY THE BRAKE WHILE BEING PUSH THROUGH A DOORWAY. OWNER'S MANUAL/ IFU SPECIFICALLY STATES: "IMPORTANT SAFETY NOTICE: DO NOT HAVE ANYONE PUSH YOU WHILE YOU ARE SEATED ON THE ROLLATOR. THIS IS A WALKING AID ONLY AND IS NOT TO BE USED AS A TRANSPORTATION DEVICE."

  Patient problems: Laceration(s)

  MAUDE report 10740778 ↗
• InjuryApr 3, 2020Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE END-USER DID NOT SEEK MEDICAL ATTENTION. HOWEVER, SINCE SHE HIT HER HEAD WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. THE END-USER WAS TRAVERSING THE LIVING ROOM UTILIZING THE DEVICE WHEN THE REAR LEFT WHEEL FELL OFF. SHE FELL AND HIT HER HEAD. SHE ACQUIRED A GASH ON HER HEAD. NO MEDICAL ATTENTION WAS SOUGHT.

  Patient problems: Fall; Laceration(s)

  MAUDE report 9924665 ↗
• InjuryAug 20, 2019Sharp Edges; Sharp Edges

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. END-USER PURCHASED A SECIBD HAND UNIT. END-USER CUT HER LEFT LEG ON THE BRAKE ASSEMBLY WHILE WALKING BEHIND THE ROLLATOR. SHE WENT TO ER AND RECEIVED STITCHES. A WEEK LATER SHE WAS REACHING FOR SOMETHING WHILE SEATED ON THE UNIT IN HER BATHROOM. SHE REACHED FOR SOMETHING. WHEN SHE PULLED HER LEG BACK SHE CAUGHT IT AND BEGAN TO BLEED. SHE WENT TO THE ER AND RECEIVED 3 STITCHES. THE END-USER IS NOT RETURNING THE UNIT FOR EVALUATION.

  Patient problems: Laceration(s)

  MAUDE report 8911762 ↗