DRIVEMEDICAL 795BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822383213484), received between Jul 24, 2019 and Apr 20, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Integrity 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT THE "BRAKES WORE DOWN, AND SHE FELL AND BROKE HER TAILBONE." 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: Multiple Fractures

  MAUDE report 16778235 ↗
• InjuryJan 31, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT HER MOTHER WAS USING THE WALKER WHEN "THE FRONT FORK BROKE AND SHE FELL, CRASHING INTO [A] VANITY," AND CAUSING HER TO "HIT HER HEAD." SHE REPORTEDLY RECEIVED MEDICAL ATTENTION AT THE SCENE FROM PARAMEDICS. 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: Head Injury

  MAUDE report 16273307 ↗
• InjuryApr 6, 2022Solder Joint Fracture; Solder Joint Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED ON (B)(6) 2022 OF AN ACCIDENT INVOLVING A ROLLATOR/TRANSPORT CHAIR. THE END USER REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY A YEAR AGO, SHE WAS BEING PUSHED IN THE UNIT BY HER DAUGHTER A FEW YEARS AGO WHEN THE FRONT LEFT WHEEL AND FORK BROKE OUT OF THE FRAME, CAUSING HER TO FALL TO THE FLOOR, HURTING HER BACK AND SHOULDER AND RESULTING IN SORENESS FOR 1 TO 2 WEEKS. SHE REPORTED THAT HER DAUGHTER ALSO FELL AT THAT TIME AND HURT HER BACK AND SHOULDER. THE END USER REPORTED THAT SHE "HAD SOMEONE REPAIR/WELD THE UNIT BACK TOGETHER," AND CONTINUED TO USE IT FOR ABOUT A YEAR, UNTIL THE FRONT LEFT WHEEL BROKE AGAIN, CAUSING HER AND HER DAUGHTER TO FALL AND INJURE THEIR BACKS AND SHOULDERS AGAIN, RESULTING IN SORENESS. DRIVE IS ATTEMPTING TO RETRIEVE THE REPAIRED UNIT FOR INSPECTION AND EVALUATION.

  Patient problems: Fall

  MAUDE report 14022302 ↗
• InjuryMar 7, 2022Material Frayed; Material Frayed

  ON (B)(6) 2021, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER'S DAUGHTER REPORTED THAT "THE BRAKE CABLE WAS FRAYED AND BROKEN," AND THAT HER MOTHER FELL WHILE USING THE ROLLATOR, CAUSING HER TO GO TO THE HOSPITAL, WHERE SHE WAS DIAGNOSED WITH "BUMPS AND BRUISES ON HER FOREHEAD," BUT NO BROKEN BONES. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT, AND WILL UPDATE THIS REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 13683863 ↗
• InjurySep 10, 2020Mechanical Jam

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE CAUGHT ON A CRACK IN THE SIDEWALK AND STOPPED ABRUPTLY. THE ENDUSER FELL AND HIT HIS HEAD CAUSING A BRUISE ON THE SIDE OF HIS HEAD.

  Patient problems: Bruise/Contusion; Fall; Head Injury

  MAUDE report 10513219 ↗
• InjuryMay 15, 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. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE CAUGHT ON A CRACK IN THE SIDEWALK AND STOPPED ABRUPTLY. THE ENDUSER FELL AND HIT HIS HEAD CAUSING A BRUISE ON THE SIDE OF HIS HEAD.

  Patient problems: Fall

  MAUDE report 10063203 ↗
• InjuryApr 29, 2020Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE PRODUCT WILL NOT BE RECOVERED FOR EVALUATION DUE TO COVID-19 PROTOCOLS. CUSTOMER WAS SITTING ON THE DEVICE AND ONE OF THE FRONT SWIVEL WHEELS BROKE COMPLETELY OFF WHERE THE FORK FASTENER GOES INTO THE FRAME. CUSTOMER FELL BACK AND HIT HER HEAD ON PORCELAIN TILE. SHE BELIEVES SHE HAD A CONCUSSION. SHE DID NOT GO TO THE HOSPITAL DUE TO COVID-19 PANDEMIC BUT CONTACTED AN ONLINE DOCTOR. PRODUCT WEIGHT CAP IS (B)(6) LBS.

  Patient problems: Fall

  MAUDE report 10012495 ↗
• InjurySep 3, 2019Device Tipped Over; Device Tipped Over

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. DRIVE'S PMS TEAM HAS NOT RECEIVED THE DEVICE FOR EVALUATION. WHEN/IF THE DEVICE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE FILED. THE END-USER WAS SHOPPING WHILE USING THE DEVICE. SHE WAS SEATED AND BENT OVER TO PUT SOMETHING IN THE BASKET AND THE ROLLATOR FLIPPED. 911 WAS CALLED AND SHE WENT TO THE ER. X-RAYS WERE TAKEN AND SHE WAS SENT HOME WITH A LEG BRACE. THE DIAGNOSIS WAS A BRUISED KNEE & PULLED MUSCLE. SHE FOLLOWED UP WITH AA PHYSICIAN DAYS LATER FOR MORE X-RAYS. SHE WENT BACK TO ER SEVERAL DAYS LATER AND THEY FOUND THAT HER MENISCUS WAS DAMAGED ALONG WITH A SMALL FRACTURE IN LEFT HIP AND A PULLED HAMSTRING. SHE STAYED AT THE HOSPITAL FOR SEVERAL DAYS BEFORE BEING TRANSFERRED TO REHAB FOR SEVERAL WEEKS.

  Patient problems: Bruise/Contusion; Hip Fracture

  MAUDE report 8956214 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. CONSUMER REPORTEDLY SLID OFF THE SEAT AND BROKE HER ARM BECAUSE THE "FOOTREST FLIPPED BACKWARDS". OUR TECH SUPPORT HAS ADVISED THAT THE PROPER USE OF THE DEVICE WOULD REQUIRE THE USER TO REST THEIR FEET ON THE FOOTREST WHILE IN MOTION. THE FOOTRESTS CANNOT FLIP BACKWARDS IN THIS INSTANCE. IF THE USER WAS STANDING ON THE FOOTREST TO EXIT THE DEVICE THE DEVICE WOULD FLIP FORWARD AND JOSTLE THE USER. THIS IS NOT RECOMMENDED. WE AWAIT RETURN OF THE DEVICE FOR EVALUATION.

  Patient problems: Fracture, Arm

  MAUDE report 8824425 ↗