DRIVEMEDICAL 10266HD-BKRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00822383931654), received between Jul 7, 2022 and Sep 9, 2025 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Break; Break

  PER DRIVE DEVILBISS HEALTHCARE MDR 2438477-2025-00037: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE PROVIDER, WHO STATED THAT THE END USER SAT ON THE ROLLATOR, THE METAL SUPPORT ABOVE THE LEFT WHEEL BROKE CAUSING THE WHEEL TO BEND AND THE END USER TO FALL AND HIT HIS HEAD ON THE FLOOR. THE END USER SUSTAINED A LACERATION ON HIS SCALP AND SUBSEQUENTLY RECEIVED SEVEN STAPLES. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Laceration(s)

  MAUDE report 23002939 ↗
• InjuryAug 13, 2025Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE PROVIDER, WHO STATED THAT THE END USER SAT ON THE ROLLATOR, THE METAL SUPPORT ABOVE THE LEFT WHEEL BROKE CAUSING THE WHEEL TO BEND AND THE END USER TO FALL AND HIT HIS HEAD ON THE FLOOR. THE END USER SUSTAINED A LACERATION ON HIS SCALP AND SUBSEQUENTLY RECEIVED SEVEN STAPLES. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Laceration(s)

  MAUDE report 22795494 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER DRIVE DEVILBISS HEALTHCARE MDR #2438477-2024-00004: 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 18578698 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT REGARDING A ROLLATOR FROM AN END USER, WHO REPORTED THAT SHE FAINTED. WHEN SHE FELL, SHE REPORTEDLY CUT HERSELF ON THE ROLLATOR'S "BACK BRAKE." SHE DID NOT IDENTIFY ANY SPECIFIC DEFECT OR MALFUNCTION IN THE ROLLATOR. THE END USER, WHO IS DIABETIC, REPORTED RECEIVING 19 STITCHES AND DEVELOPING A BLOOD INFECTION, FOR WHICH SHE WAS HOSPITALIZED. DRIVE IS CURRENTLY ATTEMPTING TO INVESTIGATE THE INCIDENT, INCLUDING INSPECTING THE PRODUCT THROUGH THE END USER'S ATTORNEY. DRIVE WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 18537919 ↗
• InjuryAug 29, 2022Defective Component; Defective Component

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S FAMILY MEMBER, WHO REPORTED THAT A "SPRING CAME UNSCREWED," AND THAT WHEN SHE WENT TO SIT ON THE UNIT, SHE FELL TO THE GROUND[?]DUE TO BRAKE FAILURE." END USER REPORTEDLY FELL AND HIT HER HEAD BUT DID NOT SEEK 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: Head Injury

  MAUDE report 15313509 ↗
• InjuryJul 7, 2022Unintended Movement; Unintended Movement

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY AN END USER OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER WAS SITTING ON THE UNIT WHILE BEING PUSHED, IN DIRECT CONTRAVENTION OF ON-PRODUCT WARNINGS AGAINST USING THE UNIT AS A TRANSPORTATION DEVICE, AND THE INSTRUCTIONS FOR USE, WHICH STATE: "DO NOT MOVE ROLLATOR WHILE SEATED. THIS IS A WALKING AID ONLY AND IS NOT TO BE USED AS A TRANSPORTATION DEVICE." THE DEVICE HIT A CRACK ON THE GROUND, AND THE END USER FELL BACKWARDS, HITTING HIS HEAD. HE REPORTED EXPERIENCING NUMBNESS AND TINGLING IN HIS FINGERS FOLLOWING THE FALL BUT DID NOT SEEK MEDICAL ATTENTION. THE ROOT CAUSE OF THE INCIDENT IS MISUSE, AGAINST WHICH END USERS ARE SPECIFICALLY WARNED. 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 14949776 ↗