Drive 10289RDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00822383259338), received between Nov 27, 2019 and Mar 12, 2024 — classified as 6 injuries.

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

• InjuryMar 12, 2024Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S DAUGHTER, WHO REPORTED THAT THE "RIVET HOLDING THE HANDLE FOR THE LEFT BRAKE FELL OUT" AND CAUSED THE END USER TO FALL AND BREAK HER HIP. DRIVE DEVILBISS HEALTHCARE IS IN THE PROCESS OF FACILITATING THE RETURN OF THE PRODUCT FOR EVALUATION AND WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 18890445 ↗
• InjuryJul 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S WIFE, WHO STATED THAT "HER HUSBAND WAS WALKING IN THE HOUSE AND HAD A SERIOUS FALL." THERE WAS NO INFORMATION PROVIDED REGARDING ANY DEFECT, AND THE END USER'S WIFE STATED THAT SHE WAS "UNSURE OF WHAT CAUSED THE FALL." THE END USER CUT HIS ARM AND INJURED HIS SHOULDER. PARAMEDICS RESPONDED AND TRANSPORTED THE END USER TO THE HOSPITAL, WHERE HE WAS ADMITTED. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 17321459 ↗
• InjuryNov 16, 2022Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT THE UNIT'S "HANDLEBAR SNAPPED AND CAUSED THE PATIENT TO FALL." THE PRODUCT WAS RETURNED TO DRIVE FOR EVALUATION, BUT THE ROOT CAUSE COULD NOT BE DETERMINED UPON VISUAL INSPECTION. DRIVE IS COORDINATING WITH EXTERNAL MATERIALS EXPERTS TO DETERMINE WHETHER IT IS POSSIBLE TO IDENTIFY THE ROOT CAUSE. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s); Scar Tissue

  MAUDE report 15807200 ↗
• InjurySep 15, 2022Material Separation; Material Separation

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO REPORTED THAT "I WAS ENTERING A BATHROOM GOING OVER A SMALL THRESHOLD WHEN THE FRONT WHEEL OF MY WALKER BROKE OFF AND I FELL AND BROKE LEFT ELBOW." SURGERY WAS NOT AN OPTION BECAUSE OF UNRELATED MEDICAL CONDITIONS. THE END USER REPORTS NOW USING IBUPROFEN TO MANAGE HER ELBOW PAIN. DRIVE MADE MULTIPLE ATTEMPTS TO RETRIEVE THE UNIT FOR EVALUATION, WITH NO RESPONSE. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall

  MAUDE report 15432067 ↗
• InjuryOct 4, 2021Break; Break

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL DATA IS AVAILABLE. WHILE IN USE THE CASTER BROKER OFF OF THE UNIT. THE USER FELL AND HIT HER HEAD. SHE ALSO ACQUIRED SCRAPES ON HER ARMS. SHE DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Easy Bruising; Fall

  MAUDE report 12573824 ↗
• InjuryNov 27, 2019Fracture; Fracture

  (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE END-USER DISCARDED TWO UNITS. BOTH UNITS WERE DISCARDED MAKING US UNABLE TO PERFORM AN EVALUATION. THE CAREGIVER ADVISED THAT THE END-USER HAD TWO OF THESE DEVICES AND BOTH UNITS THE BOLT BROKE IN HALF LEAVING PART OF THE BOLT IN THE STEM WHILE, SHE WAS WALKING WITH THE UNIT. BOTH TIMES SHE REPORTEDLY FELL. IN ONE INSTANCE THE END-USER WENT DOCTOR SEVERAL TIMES. IN THE SECOND INSTANCE WAS TAKEN TO THE ER AND THEN FOR FOLLOW UP TREATMENT AT HER PRIMARY CARE DOCTOR. SHE HIT HER NOSE ON THE CONCRETE AND HURT HER RIGHT LEG, WHICH GOT INFECTED.

  Patient problems: Fall; Laceration(s)

  MAUDE report 9384732 ↗