Drive RTL10266-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383576817), received between Oct 5, 2020 and Dec 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanical 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.

• InjuryDec 9, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO STATED THAT THE REAR WHEEL FELL OFF, CAUSING HER TO FALL AND HIT HER SHOULDER AND HEAD ON THE KITCHEN TABLE. PARAMEDICS RESPONDED TO THE SCENE BUT THE END USER REFUSED TO GO TO THE HOSPITAL. THE END USER WAS EVENTUALLY DIAGNOSED BY HER PHYSICIAN WITH A TORN DELTOID MUSCLE IN HER LEFT ARM AND AN INJURY TO HER QUADRICEP MUSCLE, AND IS RECEIVING PHYSICAL THERAPY. DRIVE DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 18298177 ↗
• InjuryDec 8, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO STATED THAT THE REAR WHEEL FELL OFF, CAUSING HER TO FALL AND HIT HER SHOULDER AND HEAD ON THE KITCHEN TABLE. PARAMEDICS RESPONDED TO THE SCENE BUT THE END USER REFUSED TO GO TO THE HOSPITAL. THE END USER WAS EVENTUALLY DIAGNOSED BY HER PHYSICIAN WITH A TORN DELTOID MUSCLE IN HER LEFT ARM AND AN INJURY TO HER QUADRICEP MUSCLE, AND IS RECEIVING PHYSICAL THERAPY. DRIVE DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 18291682 ↗
• InjuryNov 4, 2020Material Deformation; Material Deformation

  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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. END-USER WAS WALKING ALONG THE HARBOR WHEN SHE NOTICED THAT THE WHEEL WAS WOBBLING. THEY INSPECTED THE DEVICE AND NOTICED THAT THE WHEEL WAS BENT INWARD. SHE CONTINUED TO USE THE DEVICE AND THE FRONT WHEEL BUCKLED CAUSING THE ROLLATOR TO COLLAPSE. END-USER FELL HITTING HER HEAD ON THE CEMENT. SHE WAS TAKEN TO THE EMERGENCY ROOM WHERE TESTS WERE PERFORMED. NO SERIOUS INJURY WAS SUSTAINED. HISTORICAL DATA FOR COMPLAINTS OF THE SAME NATURE WAS REVIEWED AND FOUND TO BE VERY LIMITED WITH NO TREND. THERE WAS A .0442 PERCENT DEFECT RATE OVER THE LAST TWO YEARS.

  Patient problems: Fall

  MAUDE report 10788889 ↗
• InjuryOct 5, 2020Crack; Crack

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS REPORT IS BEING FILED AS PART OF AN MDR REGRESSION ANALYSIS. END-USER WAS WALKING HER DOG WITH THE DEVICE. SHE REPORTED THAT SHE WAS LEANING ON THE LEFT HAND SIDE OF THE DEVICE AND THE FRAME NEAR THE HANDLE BARS GAVE WAY. SHE FELL TO THE GROUND, WAS UNCONSCIOUS, AND BROKE HER NOSE. SHE WAS TAKEN TO THE HOSPITAL BY AMBULANCE. SHE WAS DIAGNOSED WITH A CONCUSSION AND A BRUISED NOSE. THE UNIT WAS RETURNED AND EVALUATED AND CLASSIFIED AS DEFECTIVE : DEFECTIVE: A PRODUCT THAT AFTER USE SHOWS AN INABILITY TO MEET ITS INTENDED DESIGN FUNCTIONALITY DUE TO A DETERMINED FACTOR. THE BREAK WAS ON THE LEFT FRAME NOT THE HANDLE. THERE WAS A CONFIRMED DEFECT ON THE LEFT SIDE OF THE FRAME. HOWEVER, THE DEFECT DID NOT GO THROUGH TO THE OTHER SIDE OF THE FRAME NOR DID IT CAUSE THE FRAME TO FALL APART. THIS MAY HAVE BEEN DUE TO A HORIZONTAL FORCE PLACED ON THE UNIT, CAUSING STRESS AND THE UNIT TO CRACK. THERE IS A BAGGAGE CLAIM TAG ON THE UNIT FOR FLIGHT DL 0574 AS WELL AS A WIRE ON THE BACKREST ADJUSTMENT KNOB. HISTORICAL DATA ON COMPLAINT SHOWS THAT THIS WAS AN ISOLATED INCIDENT. ROOT CAUSE CANNOT BE DETERMINE

  Patient problems: Bruise/Contusion; Concussion

  MAUDE report 10630658 ↗