Drive R800KD-RDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00822383004235), received between Aug 29, 2022 and Nov 12, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER REPORTED THAT WHEN ATTEMPTING TO SIT ON THE ROLLATOR, THE BRAKES DID NOT ENGAGE, CAUSING THE ROLLATOR TO MOVE AWAY. AS A RESULT, THE END USER FELL AND WAS UNABLE TO GET UP. EMERGENCY MEDICAL SERVICES WERE CONTACTED, AND THE END USER WAS TRANSPORTED TO A HOSPITAL, WHERE SHE WAS ADMITTED FOR APPROXIMATELY TWO WEEKS. THE END USER STATED SHE WAS UNABLE TO WALK FOLLOWING THE FALL AND REPORTED THAT SHE HAD NO BROKEN BONES BUT HER ONE LEG WAS SWOLLEN. AFTER DISCHARGE FROM THE HOSPITAL, THE END USER WAS TRANSFERRED TO A NURSING HOME FOR APPROXIMATELY TWO MONTHS. THE END USER IS CURRENTLY USING THE DEVICE AND HAS BEEN INSTRUCTED TO NOT USE THE DEVICE. AS PART OF ITS STANDARD COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL NOTIFY THE PRODUCT MANUFACTURER OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23535166 ↗
• InjuryJan 15, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S SON WHO REPORTED THAT THE FRONT LEFT WHEEL FELL OFF CAUSING THE END USER TO FALL AND HIT THEIR HEAD. THE END USER SUSTAINED A HEAD INJURY THAT REQUIRED SURGERY AND IS CURRENTLY IN A COMA. THE END USER'S SON IS NOT RELEASING THE DEVICE AT THIS TIME. THE USER'S MANUAL INSTRUCTS THE USER TO BE SURE THAT BOTH KNOBS ARE FULLY TIGHTENED AND ARE AT EQUAL HEIGHTS AND TO TEST ROLLATOR FOR STABILITY BEFORE APPLYING FULL WEIGHT TO HAND GRIPS. DRIVE RECOMMENDS PERIODIC VISUAL INSPECTION OF THIS PRODUCT BY THE USER, TO ENSURE THAT ALL PARTS AND HARDWARE ARE SECURE, THAT COMPONENTS ARE IN GOOD WORKING ORDER AND NOT WORN, TORN, FRAYED, OR LOOSE, AND THAT THERE ARE NO OBSTRUCTIONS OR IMPEDIMENTS TO NORMAL, SAFE OPERATION. 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: Coma; Head Injury

  MAUDE report 21159551 ↗
• InjuryDec 4, 2024Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO STATED THAT THE DEVICE COLLAPSED WHILE IN USE, CAUSING HER TO FALL AND HIT HER HEAD, WHICH RESULTED IN A CONCUSSION. THIS WAS THE SECOND REPORTED COLLAPSE; THE FIRST ONE DID NOT RESULT IN ANY INCIDENT OR INJURY. IT IS UNCLEAR WHETHER THE END USER WAS PROPERLY LOCKING THE ROLLATOR PRIOR TO USE. AS PART OF THE COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Concussion

  MAUDE report 20846094 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER WHO STATED THAT THE END USER WAS SITTING ON THE DEVICE AND SWUNG HER LEG OUT TO THE RIGHT AND HER LEG WAS CUT BY SOMETHING ON THE DEVICE. THE END USER REQUIRED STITCHES, AND A TETANUS SHOT. THE END USERS' DAUGHTER DID NOT KNOW WHAT PART OF THE DEVICE CUT THE END USER'S LEG. 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: Laceration(s)

  MAUDE report 20567834 ↗
• InjuryAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT "THE KNOB ON THE LEG FELL OUT" AND HE REPORTEDLY FELL AND INJURED HIS WRIST, FOOT, ANKLE, AND KNEE. THE END USER RECEIVED AN X-RAY WHICH REVEALED A SLIGHT FRACTURE TO HIS KNEE, AND HE WILL BE VISITING HIS PRIMARY DOCTOR TO DISCUSS HIS KNEE INJURIES. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17552138 ↗
• InjuryAug 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO REPORTED THAT "WHEN [HER MOTHER] WALKS, THE ROLLATOR IS BUMPING AGAINST HER LEGS, CAUSING BRUISING. ALSO, WHEN SHE STANDS UP, SHE'S BUMPING INTO THE BRAKES, AGAIN EATING HER LEGS." THE END USER SOUGHT TREATMENT IN THE EMERGENCY ROOM, WHERE IT WAS DETERMINED THAT HER LEGS WERE INFECTED, AND SHE WAS TREATED WITH ANTIBIOTICS." THE DAUGHTER REPORTED THAT HER MOTHER'S DOCTOR "BELIEVES THAT THE DESIGN OF THE ROLLATOR IS NOT MADE FOR HER BODY TYPE." DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Easy Bruising; Skin Infection

  MAUDE report 15315995 ↗