Drive R728BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822383233246), received between Dec 4, 2019 and Jun 20, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionJun 20, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER, WHO STATED THAT "THE RIGHT BACK LEG SNAPPED," REPORTEDLY CAUSING HIM TO FALL AND INJURE HIS RIGHT HIP. WHILE HE HAS YET TO RECEIVE MEDICAL TREATMENT, HE STATED HE IS IN THE PROCESS OF SCHEDULING AN X-RAY AND A CHIROPRACTOR APPOINTMENT TO ADDRESS THE INJURIES. 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: Fall

  MAUDE report 17165081 ↗
• InjuryMay 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER WHO STATED SHE SUSTAINED "A BROKEN RIGHT WRIST, BRUISED SHOULDER AND POSSIBLE CRACKED RIBS," FOR WHICH SHE RECEIVED X-RAYS, BUT DID NOT DESCRIBE HOW THE ROLLATOR CONTRIBUTED TO THE INJURIES. THE END USER REQUESTED A REPLACEMENT. 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: Bone Fracture(s); Bruise/Contusion

  MAUDE report 16888572 ↗
• InjurySep 27, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT "WHEN HE RELEASED THE BRAKES TO GET UP," THE WHEEL "GAVE OUT" AND HE "FELL ON HIS BACKSIDE AND HIT HIS HEAD AND BACK." HE RECEIVED IN-PATIENT TREATMENT IN A HOSPITAL AND REHABILITATION FACILITY FOR APPROXIMATELY THREE WEEKS, AND IS NOW RECEIVING IN-HOME PHYSICAL THERAPY. 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: Fall; Head Injury

  MAUDE report 15494158 ↗
• InjurySep 19, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO REPORTED THAT "WHILE USING THE WALKER THE WHEEL BEARINGS CAME OUT CAUSING THE WHEEL TO FALL OFF AND SHE FELL." THE END USER SOUGHT TREATMENT AT A HOSPITAL, WHERE SHE REPORTEDLY HAD CT SCANS AND MRIS, HOWEVER, DID NOT REPORT THE RESULTS OF THOSE STUDIES. 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: Fall

  MAUDE report 15447516 ↗
• InjuryMar 3, 2022Unintended System Motion; Unintended System Motion

  FROM DRIVE DEVILBISS: DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT TO BE TIMELY. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. WHILE IN USE THE BRAKES FAILED TO LOCK AND THE USER FELL. HE SOUGHT MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 13658238 ↗
• InjuryMar 2, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  DRIVE DEVILBISS WAS NOTIFIED OF SEVERAL INCIDENTS REGARDING A ROLLATOR FROM THE END USER. SHE STATED THAT "THE BRAKES HAVE ALREADY HAD TO BE FIXED 6 TIMES AND NOW THEY ARE UNREPAIRABLE AS THE WIRES ARE COMING OUT." SHE RECEIVED A CUT ON HER HAND FROM A FRAYED CABLE WHICH WAS TREATED WITH PEROXIDE AND A BANDAGE. SHE CONTINUED TO USE THE BROKEN DEVICE ALTHOUGH SHE NOTED THE BRAKES WERE NOT FUNCTIONING PROPERLY WHICH RESULTED IN A FALL IN WHICH SHE FRACTURED HER L7. SHE HAS BEEN ADMITTED TO THE HOSPITAL. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.

  Patient problems: Laceration(s); Vertebral Fracture

  MAUDE report 13655984 ↗
• InjuryNov 2, 2021Unintended System Motion; Unintended System Motion

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT TO BE TIMELY. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. WHILE IN USE THE BRAKES FAILED TO LOCK AND THE USER FELL. HE SOUGHT MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 12741836 ↗
• InjuryJun 10, 2020Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WALKER. OUR POST MARKET TEAM WAS NOTIFIED OF THE EVENT THROUGH A LEGAL LETTER. WE HAVE NO ACCESS TO THE DEVICE FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION IN ORDER TO BE TIMELY. A FOLLOW-UP WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. AT THE TIME OF THE INCIDENT, THE ENDUSER WAS UTILIZING HER R728BL WALKER. THE BACK LEFT WHEEL REPORTEDLY BECOME DISLODGED FROM THE AXLE. CONSEQUENTLY,SHE LOST HER BALANCE AND FELL TO THE GROUND. THE EXTENT OF THE INJURIES ARE UNKNOWN. PRE-EXISTING CONDITIONS ARE UNKNOWN.

  Patient problems: Fall

  MAUDE report 10141007 ↗
• InjuryDec 4, 2019Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHC ARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. WE HAVE RECEIVED PHOTOS OF THE DEVICE. IT HAS NOT BEEN RETURNED FOR EVALUATION. CONSUMER HAS BEEN UTILIZING THE UNIT FOR APPROXIMATELY SIX (6) YEARS. IN THE HOSPITAL AFTER UNDERGOING AN UNRELATED PROCEDURE THE DEVICE SNAPPED AT THE CROSSBAR WHILE HE WAS SEATED. HE FELL TO THE FLOOR. HE NOTED THAT THERE WAS INITIALLY NO PAIN THEREFORE NO FOLLOWUP ACTION. HE COMPLAINED THAT OVER TIME THERE IS INCREASE OF BACK ACHES AND INTERRUPTED SLEEP. HE BECAME BED RIDDEN TWO MONTHS LATER THE END-USER WENT TO THE ER. HE WAS DIAGNOSED WITH A PINCHED NERVE,SLIPPED DISC, AND A SMALL PELVIS FRACTURE.

  Patient problems: Fall

  MAUDE report 9410298 ↗