Drive 10257BL-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00822383290331), received between Oct 18, 2019 and Jul 23, 2025 — classified as 12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THE RIGHT FRONT CASTER/WHEEL LOCKED UP CAUSING THE END USER TO FALL. THE END USER HAD AN OLDER SPINAL FUSION PROCEDURE. THE USER FELT THE FALL EXACERBATED THE PRIOR INJURY AND HE HAD A SUBSEQUENT LAMINECTOMY. THE END USER THOUGHT HE WAS USING THE DEVICE INCORRECTLY AND CONTINUED TO USE THE DEVICE AND HAD FALLEN APPROXIMATELY 8 MORE TIMES WITH NO FURTHER INJURY REPORTED. 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: Back pain

  MAUDE report 22577834 ↗
• InjuryFeb 6, 2025Adverse 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 THE END USER, WHO STATED THAT WHILE TRYING TO USE THE DEVICE TO SUPPORT HERSELF WHILE RISING FROM A SEATED POSITION, THE UNIT WENT SIDEWAYS, CAUSING HER TO FALL AND RESULTING IN A CONCUSSION AND BRUISING ON HER FACE, NECK, HEAD. SHE SPECIFICALLY REPORTED THAT BECAUSE SHE DOES NOT REMEMBER THE MOMENT WHEN SHE FELL, SHE DOES NOT KNOW IF THE DEVICE MALFUNCTIONED AND CAUSED THE FALL. AFTER THE FALL, THE DEVICE WAS FOUND TO HAVE A BENT WHEEL WITH A CRACKED SPOKE, BUT IT WAS UNCLEAR WHETHER THIS CONDITION EXISTED BEFORE OR AS A RESULT OF THE INCIDENT. 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: Bruise/Contusion; Concussion

  MAUDE report 21327227 ↗
• InjuryNov 6, 2024Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO STATED THAT THE FRONT RIGHT FORK ASSEMBLY BROKE OFF WHILE IN USE. THE END USER FELL AND TORE HIS ACL AND WAS HOSPITALIZED. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. 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: Damage to Ligament(s)

  MAUDE report 20624147 ↗
• InjuryMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THE FRONT LEFT FORK/CASTER ASSEMBLY BENT WHILE IN USE CAUSING HER TO FALL AND HIT HER HEAD ON THE PAVEMENT RESULTING IN A BRAIN BLEED, HOSPITAL STAY AND REHABILITATION. 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: Brain Injury

  MAUDE report 19393663 ↗
• InjuryDec 18, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY A LETTER FROM AN ATTORNEY, WHICH ALLEGES THAT "THE FOLDING HINGE ASSEMBLY OF THE ROLLATOR FAILED AS THE END USER SAT DOWN ON THE DEVICE'S SEAT," CAUSING THE END USER TO FALL BACKWARDS. THE ATTORNEY FURTHER ALLEGES THAT AS A RESULT, THE END USER "BROKE HIS BACK" AND HAS BEEN IN A BACK BRACE SINCE THE INCIDENT. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE PRODUCT THROUGH THE ATTORNEY. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18348331 ↗
• MalfunctionJun 8, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT THE "LEG FRAME WAS BROKEN," WHICH REPORTEDLY CAUSED THE END USER TO FALL OFF AND "HIT HIS HEAD ON [A] COUNTER." IT IS NOT CLEAR WHETHER THE FRAME WAS BROKEN DURING THE REPORTED INCIDENT, OR BEFORE. THE REPORTER CONFIRMED THAT THERE WAS NO ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE PROCESSED A REPLACEMENT FOR THE END USER. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Head Injury

  MAUDE report 17087151 ↗
• InjurySep 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO REPORTED THAT "SHE RECEIVED A WOUND CAUSED BY THE BRAKE. SHE WAS TAKEN BY AMBULANCE TO THE EMERGENCY ROOM AND TREATED. SHE HAS BEEN TREATED FOR THREE MONTHS AT WOUND CLINICS AS WELL." DRIVE MADE MULTIPLE ATTEMPTS TO RETRIEVE THE UNIT. THE END USER STATED SHE "WILL NOT BE ABLE TO RETURN THE UNIT" FOR EVALUATION. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 15438388 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED A REPORT OF AN INCIDENT INVOLVING A ROLLATOR FROM AN END USER, WHO REPORTED THAT WHILE HE WAS SEATED IN THE ROLLATOR, THE "SEAT CRACKED AND COLLAPSED," CAUSING HIM TO FALL AND SUSTAIN A TORN ROTATOR CUFF, AS WELL AS PAIN IN HIS NECK AND SHOULDERS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 15362924 ↗
• InjuryJul 11, 2022Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT THE LEFT LEG CASTER "COLLAPSED WHILE THE BRAKES WERE ENGAGED, AND THE DEVICE WAS STATIONERY," CAUSING HIM TO FALL BACKWARDS ONTO A CONCRETE PATH, HITTING HIS HEAD, SCRATCHING THE BACK OF HIS LEFT LEG, AND AGGRAVATING AN EXISTING BACK INJURY. THE END USER REPORTED THAT THE "HARDWARE CAME LOOSE AND CAUSED FOR TO DETACH FROM STEM." THE END USER DECLINED TO RETURN THE UNIT FOR EVALUATION.

  Patient problems: Fall; Head Injury

  MAUDE report 14978294 ↗
• InjuryJul 7, 2022Adverse 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 15-YEAR-OLD ROLLATOR THAT OCCURRED IN (B)(6) 2020. THE END USER REPORTED THAT WHILE TRAVERSING UNEVEN GROUND USING A ROLLATOR THAT SHE USED SUCCESSFULLY FOR 15 YEARS, SHE FELL AND SUSTAINED BACK AND NECK INJURIES, RESULTING IN HOSPITALIZATION, SURGICAL INTERVENTION, AND COMPLICATIONS. THREE OF HER VERTEBRAE WERE REMOVED. WHILE RECUPERATING SHE SUFFERED PNEUMONIA LEADING TO FURTHER HOSPITALIZATION. DRIVE IS ATTEMPTING TO EVALUATE THE UNIT THROUGH THE ATTORNEY AND WILL PROVIDE AN UPDATE WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall

  MAUDE report 14946150 ↗
• InjurySep 13, 2021Unintended Movement; Unintended Movement

  (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR.. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IT IS SIX YEARS OLD. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION AND TO BE TIMELY. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS ACQUIRED. INITIAL REPORT STATED THAT END-USER WAS SITTING ON HIS DEVICE AND THE SEATING PAD BROKE. HE FELL ON THE CEMENT AND WE HAD TO TAKE HIM TO THE ER. SUBSEQUENT REPORT STATED THAT THE END-USER WAS SITTING ON THE DEVICE IN HIS YARD. HE REPORTED THAT THE BRAKES SUDDENLY FAILED AND HIS DEVICE SPUN AROUND MULTIPLE TIMES. HE FELL TO THE PAVEMENT AND WAS TAKEN TO THE EMERGENCY ROOM. X-RAYS DETECTED NO BROKEN BONE. HE WAS SCRAPED UP AND GIVEN TYLENOL FOR THE PAIN. HIS CAREGIVER STATED THAT HE IS IN PHYSICAL AND OCCUPATIONAL THERAPY AND REQUIRES A NURSE ATTENDANT.

  Patient problems: Abrasion; Fall

  MAUDE report 12465102 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. DEICE WAS NOT RETURNED FOR EVALUATION AS IT WAS A CUSTOMER USE ERROR. END-USER WAS EXITING AN ELEVATOR WHEN HIS FOOD CAUGHT ON THE RUG. HE WAS HOLDING THE LOOP BRAKE AS HE FELL AND HE BRAKE BROKE. HE HIT HIS HEAD. HE WAS TAKEN TO THE HOSPITAL AND RECEIVED STITCHES.

  Patient problems: Laceration(s)

  MAUDE report 10885151 ↗
• InjuryOct 18, 2019Unintended Movement; Unintended Movement

  (B)(4) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RETRIEVED THE DEVICE FOR EVALUATION. END-USER IS REQUESTING COMPENSATION FOR (B)(4) BILLS. END-USER WAS SITTING ON THE DEVICE. WHEN SHE GOT UP THE HANDGRIP REPORTEDLY SLIPPED COMPLETELY FORWARD. SHE WENT FORWARD WITH THE GRIP AND HIT THE FLOOR. SHE INJURED HER RIGHT SIDE AND ANKLE. THE FIRE DEPARTMENT ASSISTED HER AND BROUGHT HER TO THE ER. SHE WAS DIAGNOSED WITH A BROKEN ANKLE AND FIBULA, GIVEN A BOOT AND DIRECTED TO SEE A SPECIALIST.

  Patient problems: Bone Fracture(s)

  MAUDE report 9207701 ↗