Drive 10289BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383259345), received between Nov 2, 2017 and Mar 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2025Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN ATTORNEY, WHO ALLEGED THAT THE CLIENT WAS INJURED WHEN HER ROLLATOR FAILED DURING USE RESULTING IN WOUNDS AND A BROKEN NOSE. 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: Bone Fracture(s); Laceration(s)

  MAUDE report 21504893 ↗
• InjuryJul 5, 2023Break; Break

  (B)(6) WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER WHO STATED THAT "THE FRONT WHEEL BROKE OFF AND THE UNIT BROKE WHILE CROSSING THE STREET." THE END USER WAS TREATED AT AN URGENT CARE FACILITY, WHERE HER WRIST AND KNEE WERE BANDAGED. DRIVE REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 17262488 ↗
• InjuryNov 2, 2017Bent; Collapse

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE. END-USER WAS USING DEVICE IN THE HOME IN AN AREA WHERE OUTDOOR CARPET AND TILES CONVERGED. AT THE BUMP IN THE FLOORING THE FRONT WHEEL COLLAPSED. SHE FELL AND FRACTURED HER FOOT. THE ITEM WAS RETURNED AND EVALUATED. ITEM RETURNED ON RMA (B)(4) HAD A COMPLAINT OF THE FRONT WHEEL COLLAPSING. THE UNIT SHOWS MODERATE USE WITH NO SIGNIFICANT DAMAGE TO THE FRAME OR WHEELS. THE BRAKES ON BOTH SIDES ARE CONFORMING. THE FRONT WHEEL HAS BENT FORWARD AND DOWNWARD BUT SHOWS NO DAMAGE TO THE WHEEL OR FRONT FORK. ROOT CAUSE MAY BE ATTRIBUTED TO MATERIAL DAMAGE DUE TO WELDING. THE NORMAL STRUCTURE MAY NOT HAVE BEEN STRONG ENOUGH DUE TO DAMAGED MATERIAL.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 6998165 ↗