Drive 10243Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383138107), received between May 29, 2020 and Nov 25, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WALKER BY THE END USER WHO REPORTED THE FRONT WHEEL BROKE OFF WHILE IN USE CAUSING THE END USER TO FALL ONTO HER LEFT SIDE AND HIT HER HEAD. THE END USER HAD TESTING COMPLETED AT THE HOSPITAL THAT SHOWED BRUISING AND INFLAMMATION TO HER LEFT ARM AND LEG AND WAS PRESCRIBED PAIN MEDICATION, ORAL ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION. 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; Swelling/ Edema

  MAUDE report 23647630 ↗
• MalfunctionJun 20, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER, WHO STATED THAT THE "FRONT LEFT LEG CRUMPLED UNDER HIS WEIGHT WHEN HE SAT DOWN ON THE SEAT," AND HE REPORTEDLY FELL AND SUSTAINED A BRUISED ARM AND SCRAPED KNEE. THE END USER CONFIRMED THAT HE DID NOT RECEIVE ANY MEDICAL TREATMENT. 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 17165125 ↗
• InjurySep 6, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A WALKER FROM THE END USER, WHO REPORTED THAT SHE "TRIED TO SIT ON WALKER, AND THE BACK STRAP BROKE. SHE FELL AND HIT HER HEAD ON THE CONCRETE, AND HER ELBOW WAS ALSO BLEEDING. HER HIP WAS ALSO INJURED." THE END USER DID NOT GO TO THE EMERGENCY ROOM BUT SOUGHT MEDICAL TREATMENT WITH HER PRIMARY PHYSICIAN, WHO ADVISED HER TO REST. X-RAYS OF HER HIP WERE NEGATIVE. THE END USER DECLINED TO RETURN THE UNIT TO DRIVE FOR EVALUATION.

  Patient problems: Head Injury

  MAUDE report 15363427 ↗
• InjuryMay 29, 2020Material Twisted/Bent; Material Twisted/Bent

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. THE END-USER WAS SITTING IN THE DRIVEWAY ON THE UNIT WHEN THE ENTIRE LEFT SIDE REPORTEDLY COLLAPSED. HE FELL,HITTING HIS HEAD ON THE BLACKTOP. THE DEVICE WAS RETURNED FOR EVALUATION. THE ITEM # 10243 CLEVERLITE WALKER WAS RETURNED UNDER RMA # (B)(4) DUE TO THE LEG BENDING. THE UNIT SHOWS SIGNS OF NORMAL WEAR AND MULTIPLE COMPONENTS HAVE RUST ON IT. THE BRAKES AND THE FOLDING HINGE FUNCTION CORRECTLY. POSSIBLE ROOT CAUSE FOR THIS FAILURE WAS THAT THE USER WAS SITTING ON A LEVEL SURFACE CAUSING AN UNBALANCED LOAD ON THE LEGS.

  Patient problems: Laceration(s)

  MAUDE report 10103485 ↗