Drive R800KD-BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00822383004228), received between Oct 18, 2021 and May 27, 2026 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Break

  DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN EMAIL FROM AN ATTORNEY WHO REPORTED THE END USER WAS SITTING ON THE ROLLATOR WHEN THE PIN CAME OUT OF THE LEG CAUSING THE BACK WHEEL TO COME OUT. THE END USER FALL BACKWARDS RESULTING IN SWELLING AND ABRASIONS TO HER KNEES AND ELBOW. THE END USER WAS EVAULATED AT AN EMERGENCY ROOM AND WAS DISCHARGED THE SAME DAY. THE END USER REQUIRED PHYSICAL THERAPY FOR THEIR BACK AND KNEES. DRIVE MEDICAL IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Abrasion; Swelling/ Edema

  MAUDE report 25303752 ↗
• InjuryDec 3, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S DAUGHTER. THE REPORT STATED THAT THE END USER WAS ASCENDING A RAMP WHEN THE BRAKES FAILED TO ENGAGE. AS A RESULT, THE END USER SLIPPED, FELL TO THE GROUND, AND WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE THEY WERE DIAGNOSED WITH A FRACTURED PELVIS. THE DEVICE WAS RETURNED FOR EVALUATION. BRAKE FUNCTIONALITY WAS TESTED AND CONFIRMED TO OPERATE AS INTENDED; HOWEVER, INSPECTION REVEALED THAT THE WHEEL WAS SIGNIFICANTLY WORN DOWN. THIS WEAR PREVENTED PROPER CONTACT BETWEEN THE BRAKE LEVER AND THE WHEEL SURFACE, CAUSING THE BRAKE TO SLIP. DUE TO THE WHEEL'S CONDITION, ALTHOUGH THE BRAKE LEVER ENGAGED, THE WHEEL CONTINUED TO SLIP, RENDERING THE BRAKING SYSTEM INEFFECTIVE. 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. IF ANY PART OR MECHANISM APPEARS TO BE UNSAFE OR COMPROMISED, DO NOT USE THE PRODUCT. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEV

  Patient problems: Bone Fracture(s)

  MAUDE report 23707607 ↗
• InjuryDec 2, 2025Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN ATTORNEY LETTER ALLEGING THAT "DUE TO DEFECTIVE DESIGN, CONSTRUCTION, AND WELDING, THE WALKER BROKE, CAUSING OUR CLIENT TO FALL AND SUSTAIN SEVERE INJURIES" DURING USE. DRIVE DEVILBISS HEALTHCARE IS ATTEMPTING TO INVESTIGATE THE INCIDENT THROUGH COOPERATION WITH THE END USER'S ATTORNEY.

  Patient problems: Pain

  MAUDE report 23692693 ↗
• InjuryJan 15, 2025Mechanical Problem; Mechanical Problem

  (B)(6) WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THAT THE BACK WHEELS CAME OFF THE DEVICE CAUSING HER TO FALL AND HIT HER HEAD. THE END USER SUSTAINED A BLACK EYE, BRUISING TO FACE, TWO SKIN TEARS, AND REOPENED A PRE-EXISTING LEG WOUND. SHE WAS HOSPITALIZED FOR FOUR DAYS FOR THE INFECTED WOUND AND RECEIVED ANTIBIOTICS. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE SHOWS SIGNS OF LIGHT WEAR. THE WHEELS WERE INSPECTED FOR DAMAGE AND DID NOT FIND ANY. THE DEVICE WAS RETURNED WITH NO ATTACHMENT KNOBS TO ADHERE THE WHEELS TO FRAME. PRODUCT LABELING STATES," ATTACH THE BACK WHEELS (WITH BRAKE HANDLES) BY INSERTING TUBE INTO THE ROLLATOR FRAME, MAKING SURE THE WHEELS ARE FACING THE OUTSIDE OF THE ROLLATOR. ALIGN HOLE ON WHEEL TUBE WITH FRAME AND SECURE IN PLACE USING THE TIGHTENING KNOB, THREADING THE KNOB ON THE INSIDE. INSERT C-CLIP ABOVE KNOB TO SECURE WHEEL IN PLACE."

  Patient problems: Wound Infection

  MAUDE report 21159549 ↗
• InjuryMar 27, 2024Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO REPORTED THAT A WHEEL FELL OUT AND CAUSED HIM TO FALL, SUSTAINING A TORN ROTATOR CUFF AND THUMB LIGAMENT, WHICH BOTH REPORTEDLY REQUIRE SURGERY. THE DEVICE IS BEING RETURNED FOR EVALUATION. DRIVE WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 18988926 ↗
• InjurySep 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A ROLLATOR BY AN END USER, STATING THAT "THE WHEEL BRAKE LEVER STICKS OUT TOO MUCH - ABOUT AN INCH PAST THE WHEEL AND IS CAUSING HER TO HIT HER ANKLES AND BE CUT." URGENT CARE REFERRED HER TO THE WOUND CARE CENTER AND SHE IS BEING TREATED FOR THESE INJURIES. STATES SHE HAD TO HAVE 11 STITCHES IN HER RIGHT ANKLE. 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: Laceration(s)

  MAUDE report 17761355 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY A PROVIDER, WHO STATED THAT "ONE OF THE FRONT WHEELS CAME OFF, [AND] THE CONSUMER FELL AND HIT HER HEAD." EMTS ARRIVED AT THE SCENE OF THE ACCIDENT BECAUSE OF THE END USER'S LIFE ALERT SYSTEM, HOWEVER SHE REFUSED TO GO TO THE EMERGENCY ROOM, AND HER DAUGHTER REPORTED THAT SHE WOULD BE TAKING HER MOTHER TO AN URGENT CARE FACILITY. 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: Fall; Head Injury

  MAUDE report 17354566 ↗
• InjuryOct 18, 2021Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT TIN AN OVERABUNDANCE OF CAUTION AND TO BE TIMELY. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL DATA BECOMES AVAILABLE. WHILE IN USE THE ;EFT BACK WHEEL CRUSHED AND DISMANTLED. THE USER FELL TO THE GROUND. IT TOOK HER REPUTEDLY TEN (10) MINUTES TO GET UP. FROM THE FLOOR. SHE WENT TO THE HOSPITAL AND NOTHING WAS BROKEN. SHE REQUIRES HIP AND KNEE REPLACEMENT SURGERY. THIS INCIDENT HAS EXACERBATED THE EXISTING INJURIES.

  Patient problems: Easy Bruising; Fall

  MAUDE report 12646428 ↗