Drive RTL10266CFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00822383523934), received between May 3, 2021 and Aug 24, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER WHO STATED THAT A WHEEL BROKE AND "SENT [HER] BACKWARDS ONTO THE FLOOR." THE END USER WAS REPORTEDLY TAKEN TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH SHOULDER FRACTURES AND DISLOCATION. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17615306 ↗
• InjuryApr 19, 2023Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING ROLLATOR BY AN END USER, WHO STATED THAT THE "BRAKE ASSEMBLY BROKE AND WHEN HE WENT TO GET UP IT WASN'T LOCKED, AND IT MOVED, AND HE ENDED UP FALLING AND FRACTURING HIS RIBS." 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); Fall

  MAUDE report 16772844 ↗
• InjuryJan 26, 2023Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT HE FELL BECAUSE THE BRAKES "WENT OUT ON HIM," REPORTEDLY CAUSING HIM TO "HIT HIS HEAD ON THE STREET" AND SUSTAIN A "GASH" THAT REQUIRED HOSPITAL INTERVENTION. IT WAS CONFIRMED THAT THE END USER NO LONGER HAS THE PRODUCT TO SEND BACK FOR EVALUATION. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall; Head Injury; Laceration(s)

  MAUDE report 16248063 ↗
• InjuryOct 12, 2022Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT THE "BRAKES DO NOT LOCK ANYMORE AND HAVE CAUSED HIM TO FALL AND HIT HIS HEAD," SUSTAINING A "GASH ON THE SIDE OF HIS HEAD." AN AMBULANCE WAS CALLED, AND HIS SON, WHO IS A DOCTOR, EXAMINED HIM, HOWEVER HE DID NOT RECEIVE ADDITIONAL MEDICAL ATTENTION. 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 15588507 ↗
• InjuryMar 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT REGARDING A ROLLATOR ON (B)(6) 2021. THE END USER HAVE BEEN USING THE DEVICE FOR ALL HER MOBILITY FOR APPROXIMATELY THREE YEARS. THE END-USER REPORTED THAT THE "THE FRONT WHEELS IS CATCHING." SHE WAS USING THE DEVICE TO GO TO THE REST ROOM AND FELL TWICE. SHE WAS ATTEMPTING TO GO IN ONE DIRECTION AND REPORTEDLY FELL SINCE THE DEVICE DID NOT ROLL PROPERLY. THERE WAS AN INITIAL INCIDENT ON (B)(6) WHEN SHE WAS TAKEN TO THE EMERGENCY ROOM. SHE CONTINUED TO USE THE DEVICE. SHE HAD A SECOND INCIDENT (B)(6) AND WAS ADMITTED TO THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY. THE END USER HAS NOT RESPONDED TO OUR INQUIRIES. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Fall

  MAUDE report 13656755 ↗
• InjuryDec 15, 2021Break; Break

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THIS COMPLAINT WAS PULLED FROM A CONSUMER REVIEW WEBSITE AND WE ARE UNABLE TO OBTAIN ANY CONTACT INFORMATION FROM THE USER .THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FRAME BROKE WHILE THE USER WAS SITTING ON HIS FRONT PORCH. HE FELL AND HIT HIS HEAD.

  Patient problems: Fall; Head Injury

  MAUDE report 13009617 ↗
• InjuryMay 3, 2021Solder Joint Fracture; Solder Joint Fracture

  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 IN AN OVER ABUNDANCE OF CAUTION. A FOLLOW-UP WILL BE FILED WHEN MORE INFORMATION IS AVAILABLE. WHILE IN USE THE ROLLATOR COLLAPSED. AS A RESULT OF THE FALL THE END-USER HIT HIS HEAD AND HIS LEGS AND ARMS WERE BRUISED. CURRENTLY THE END-USER CANNOT LOCATE THE DEFECTIVE UNIT BUT HAS AGREED TO SEND THE UNIT BACK IF LOCATED.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 11766907 ↗