Drive RTL10266Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00822383288819), received between Jun 11, 2020 and Nov 13, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Mechanical Problem; Mechanical Problem

  FROM DISTRIBUTOR'S MDR: DRIVE DEVILLBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR THAT THE CURB ASSIST BROKE AND THE END USER FELL, CUT HER HEAD AND REQUIRED 12 STITCHES. THE END USER WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS WITH A CONCUSSION AND 2 PINTS BLOOD LOSS. DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE DEVICE FOR INVESTIGATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Concussion; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 18118845 ↗
• InjuryNov 8, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILLBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR THAT THE CURB ASSIST BROKE AND THE END USER FELL, CUT HER HEAD AND REQUIRED 12 STITCHES. THE END USER WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS WITH A CONCUSSION AND 2 PINTS BLOOD LOSS. DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE DEVICE FOR INVESTIGATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Concussion; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 18095652 ↗
• InjuryAug 3, 2023Material Twisted/Bent; Material Twisted/Bent

  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)

  MAUDE report 17452696 ↗
• MalfunctionJun 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER, WHO STATED THAT "THERE IS A PART BY THE RIGHT WHEEL THAT CAUSED ME AN INJURY." THE END USER DID NOT SPECIFY WHETHER THERE WAS ANY MALFUNCTION OF THE ROLLATOR, WHAT PART WAS INVOLVED, OR WHETHER OR HOW THE PART WAS DEFECTIVE. THE END USER REPORTEDLY EXPERIENCED SWELLING AND WAS GIVEN ANTIBIOTICS AS A RESULT OF THE OTHERWISE UNSPECIFIED INJURY. 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: Swelling/ Edema

  MAUDE report 17147844 ↗
• InjuryMar 2, 2022Device Unsafe to Use in Environment; Unintended Movement; Device Unsafe to Use in Environment; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR ON JANUARY 25TH. THE USER WAS USING THE ROLLATOR GOING DOWN THE STEPS. THE BRAKES WERE PRESSED BUT DID NOT FUNCTION CAUSING THE END-USER TO FALL. THE USER STATES THAT SHE WAS HOLDING ONTO THE ROLLATOR ON THE FIRST STEP WHILE GOING TO THE NEXT STEP WITH THE BRAKES ENGAGED BUT THE ROLLATOR MOVED, AND SHE FELL TO THE NEXT STEP. HER PHYSICAL THERAPIST TRIED TO BREAK HER FALL, BUT THE HANDLEBAR POKED HER IN THE SIDE, NEXT TO HER LEFT BREAST. HE THEN HELPED HER GET INTO THE HOUSE AND NO MEDICAL ATTENTION WAS REQUIRED. THE END USER SOUGHT MEDICAL ATTENTION ON JANUARY 28TH, THROUGH X-RAY IT WAS DETERMINED THAT SHE SUFFERED TWO BROKEN RIBS . NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY. THE DEVICE IS INTENDED TO BE USED ON EVEN SURFACES NOT TRAVERSING STEPS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 13656510 ↗
• InjuryOct 6, 2021Break; Break

  (B)(6) 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 INFORMATION IS AVAILABLE. WHILE IN USE THE BOTTOM PART BAR THAT GOES ACROSS THE UNIT JUST CAME OFF CAUSING HER TO TOPPLE OVER AND ROLL DOWN THE HILL. SHE RECEIVED CUTS ON RIGHT ELBOWS AND LEFT LEG. SHE WENT TO HER FAMILY DOCTOR WHO PRESCRIBED ANTIBIOTICS WHEN HER ELBOW GOT INFECTED.

  Patient problems: Laceration(s)

  MAUDE report 12586111 ↗
• Oct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL REPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE ARE FILING THIS REPORT TO CORRECT INACCURACIES IN HTE MEDWATCH FILING MW5096025. THERE WAS NO SERIOUS INJURY, INTERVENTION REQUIRED, OR A DEVICE MALFUNCTION. THE END-USER LIVES IN A SENIOR CITIZEN RESIDENCE. WHILE ADJUSTING THE BRAKE THE CONSUMER PINCHED HIS PINKIE. IT BLED AND HER REQUIRED THE NURSE TO ASSIST. TREATMENT WAS APPLICATION OF A BANDAID.

  Patient problems: Laceration(s)

  MAUDE report 10674958 ↗
• InjuryJun 11, 2020Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION SUE TO A MDR REGRESSION ANALYSIS. THE END-USER WAS ON THE STEPS OF A SWIMMING POOL WHILE SITTING ON THE DEVICE. THE RIGHT FRONT WHEEL REPORTEDLY FELL OFF CAUSING HIM TO HIT HIS HEAD. HE RECEIVED MINOR ABRASIONS AS WELL. THE DEVICE WAS RECEIVED FOR EVALUATION. IT SHOWED NORMAL USAGE. THE BRAKES ON EACH SIDE WERE CONFORMING. THE FRONT LEFT WHEEL WAS DETACHED FROM THE UNIT. THE FRONT AXLE BOLT WAS DELIVERED WITH NO DAMAGED AND SIGNS OF STRIPPED THREADS. THE THREADS INSIDE THE FORK, HOWEVER, SHOW MINIMAL DAMAGE TO THE THREADS . THE ROOT CAUSE MAY BE ATTRIBUTED TO THESE DAMAGE THREADS FROM ASSEMBLY, CAUSING THE AXLE BOLT TO DETACH FROM THE UNIT DURING VIBRATIONS OVER TIME. THE UNIT IS DEFECTIVE HISTORICAL DATA FOR COMPLAINTS OF THE SAME NATURE WAS REVIEWED AND FOUND VERY LIMITED REPORTING WHICH SHOWS NO TREND.

  Patient problems: Fall

  MAUDE report 10146400 ↗