Drive RTL10261BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383262765), received between Mar 14, 2019 and Aug 3, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionAug 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT HE "FELL OVER WHILE SITTING ON THE UNIT" AND REPORTEDLY SCRAPED HIS HEAD, ELBOW AND KNEE. THE END USER REPORTS THAT HE DID NOT SEEK ANY MEDICAL ATTENTION AND CLAIMS THAT THE LEG OF HIS ROLLATOR HAS BROKEN. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Head Injury

  MAUDE report 17451877 ↗
• InjurySep 26, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. A PROVIDER CALLED ON BEHALF OF THE PATIENT AND STATED "THE ROLLATOR IS SEVERED COMPLETELY APART ON ONE SIDE OF THE ROLLATOR. THE WHEELS WERE COMPLETELY WORN DOWN. THE BACK BAR FOAM WAS TORN. THE PATIENT FELL AND HURT HER KNEE. HER ARM HIT THE GROUND AND HER BACK WAS HURT." PATIENT WENT TO THE ER AND GOT X-RAYS TAKEN BUT NO RESULTS HAVE BEEN SHARED WITH DRIVE. SHE SUSTAINED SCRAPES TO HER LEGS THAT RESULTED IN WOUND CARE TO REMOVE SCABBING. THE PATIENT DOESN'T HAVE THE ABILITY TO RETURN UNIT FOR EVALUATION.

  Patient problems: Fall

  MAUDE report 15485712 ↗
• InjuryMar 14, 2019Break; Break

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS AN ADJUSTABLE HEIGHT ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE HAVE IMAGES OF THE DAMAGED DEVICE FOR EVALUATION. THE END-USER WAS SITTING ON THE DEVICE WHEN THE FRAME BROKE AT THE LONGEST ADJUSTMENT BUTTON. SHE WAS USING THE DEVICE EVERY DAY FOR AT LEAST SIX MONTHS. SHE DID NOT INITIALLY SEEK MEDICAL ATTENTION. AFTER SEVERAL DAYS SHE SOUGHT MEDICAL ATTENTION AND WAS REPORTEDLY DIAGNOSES WITH A FRACTURED RIGHT FOOT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 8420768 ↗