Drive R800BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00822383524108), received between Dec 9, 2019 and Jun 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Sharp Edges” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Sharp Edges; Sharp Edges

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT HER MOTHER "SAT DOWN IN THE ROLLATOR AND HER HAND WENT DOWN ON SIDE AND WAS CUT ON THE SHARP EDGE OF THE SCREW." THE END USER REQUIRED FIVE STITCHES. 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: Laceration(s)

  MAUDE report 17166620 ↗
• InjuryDec 23, 2021Sharp Edges; Sharp Edges

  DRIVE RECEIVED A REPORT THAT THE END USER OF A ROLLATOR WAS INJURED WHEN THE ROLLATOR "PUT HOLES IN HER LEGS ON 3 OCCASIONS DUE TO BEING SHARP." THE REPORTER STATED THAT THE END USER IS ON BLOOD THINNERS AND "BLED ALL OVER THE FLOOR," AND TREATED AT AN URGENT CARE. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 13082961 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE WAS NOT IN USE DURING THE INCIDENT. IT WILL NOT BE RETRIEVED FOR EVALUATION. THE END-USER WAS GETTING UP FROM BED. REACHING FOR THE WALKER. HER LEG CAME DOWN ON THE WALKER AND SHE WAS CUT BY THE BRAKE CABLE. SHE SOUGHT MEDICAL ATTENTION AND IS CURRENTLY GOING TO WOUND CLINIC FOR CARE.

  Patient problems: Laceration(s)

  MAUDE report 10578065 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE WILL UPDATE THIS REPORT WHEN THERE IS ADDITIONAL INFORMATION AS IT BECOMES AVAILABLE. IN AN OVERABUNDANCE OF CAUTION WE FILE THIS REPORT DUE TO THE ENDUSER HITTING HER HEAD. THE ENDUSER CAUGHT HER LEG ON THE ROLLATOR AND TRIPPED. SHE FELL AND BRUISED HER HEAD. THE ROLLATOR FRAME WAS BENT FROM THE INCIDENT.

  Patient problems: Fall

  MAUDE report 9955223 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. END-USER GOT UP TO GO TO THE BATHROOM IN THE MIDDLE OF THE NIGHT IN THE DARK AND WHEN SHE GOT TO HER ROLLATOR. SHE FELT A PINCH ON HER LEG. SHE WALKED TO THE BATHROOM AND WHEN SHE TURNED THE LIGHT ON SHE SAW THAT SHE WAS BLEEDING PROFUSELY FROM HER LEG. SHE WAS ABLE TO WRAP IT UP BUT THE NEXT DAY WENT TO HER DOCTOR TO GET IT CHECKED OUT. THE DOCTOR RECOMMENDED SHE GO SEE A WOULD CARE SPECIALIST WHO SHE SAW A FEW DAYS LATER AND HAS BEEN SEEING WEEKLY SINCE. END-USER STATES THE BRAKE PAD THAT POKED THROUGH HER SKIN SEVERED A BLOOD VESSEL. HOWEVER, THE BRAKES ARE HAND BRAKES.

  Patient problems: Laceration(s)

  MAUDE report 9440931 ↗