Drive 10215BL-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00822383100647), received between Aug 12, 2020 and Jan 22, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THAT THE BACK WHEEL GOT "STUCK" CAUSING THE END USER TO FALL AND HIT HER HEAD, SUSTAINING A MILD CONCUSSION. EVALUATION OF THE PRODUCT REVEALED THAT THE BACK LEFT WHEEL FAILED TO MOVE AS INTENDED BECAUSE OF THE NEED TO ADJUST THE BRAKES. ONCE THE BRAKE WAS ADJUSTED, THE PROBLEM DID NOT RECUR. 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: Concussion

  MAUDE report 24144249 ↗
• InjuryFeb 4, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER, WHO STATED THAT WHILE USING THE ROLLATOR, THERE WAS AN UNIDENTIFIED "ISSUE WITH THE WHEEL," CAUSING HIM TO FALL. HE REPORTED THAT HE WAS UNABLE TO GET HIS HANDS OUT OF THE HANDLES FAST ENOUGH DURING THE FALL AND DISLOCATED BOTH ARMS FROM THE SHOULDER SOCKETS. 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: Joint Dislocation

  MAUDE report 21303557 ↗
• InjuryJun 28, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER, WHO STATED THAT "WHILE SITTING ON MY ROLLATOR IT BROKE. THE BOLT HOLDING THE RIGHT WHEEL SNAPPED." THE END USER WENT TO THE HOSPITAL, WHERE X-RAYS CONFIRMED TWO BROKEN 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: Fall; Multiple Fractures

  MAUDE report 17215968 ↗
• InjuryMay 1, 2023Naturally Worn; Naturally Worn

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S SISTER, WHO REPORTED THAT "THE BEARINGS ARE WORN ON THE FRONT OF ROLLATOR," AND THAT "AS HER BROTHER WAS USING THE UNIT, HE FELL DOWN," CAUSING HIM TO DISLOCATE HIS ANKLE AND INJURE HIS KNEE. THE END USER WAS REPORTEDLY TRANSPORTED VIA AMBULANCE TO A HOSPITAL, TREATED AND RELEASED, BUT REPORTEDLY RETURNED TO THE HOSPITAL AT A LATER DATE DUE TO "SEIZURES FROM STRESS." SHE STATED THAT HE WAS TAKING PAIN MEDICATION AND WAS "IN A BOOT." THE END USER'S SISTER REPORTS THAT SHE WILL NOT BE ABLE TO RETURN THE UNIT FOR EVALUATION. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16845870 ↗
• InjuryMar 30, 2023Component Missing; Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER WHO STATED THAT "THREE OF THE WHEELS BROKE OFF AFTER HITTING A POTHOLE IN THE STREET AND THEY SUSTAINED A SWOLLEN LEG AND SCRATCHES." THE END USER WAS TAKEN TO THE EMERGENCY ROOM TO TREAT HER 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; Laceration(s); Swelling/ Edema

  MAUDE report 16643218 ↗
• InjuryOct 26, 2021Fracture; Fracture

  (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP WHEN ADDITIONAL DATA BECOMES AVAILABLE. WHILE IN USE THE FORK BROKE FROM THE FRAME AND THE USER FELL. SHE WENT TO THE ER AFTER FALLING. THEY WRAPPED HER LEG IN AN ACE BANDAGE AND RECOMMENDED SHE SEE A SPECIALIST. SHE WAS GIVEN TYLENOL FOR THE PAIN. SHE SUSTAINED AN INJURY TO ER KNEE WHICH WAS DIAGNOSED AS A POSSIBLE TORN TENDON OR MENISCUS. THE SPECIALIST HAD HER TAKE AN MRI. SHE WAS PRESCRIBED THREE MEDICATIONS INCLUDING PAIN MEDS AND METROPOD.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 12696783 ↗
• InjuryMay 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL INFORMATION IS AVAILABLE. DRIVE BECAME AWARE OF THE INCIDENT THROUGH A LEGAL NOTICE. WE ARE FILING THIS REPORT IN AN OVER ABUNDANCE OF CAUTION. END-USER SUSTAINED INJURIES FROM A FALL FROM THE ROLLATOR. NO OTHER SPECIFICS ARE KNOWN.

  Patient problems: Fall; Insufficient Information

  MAUDE report 11874301 ↗
• InjuryAug 12, 2020Fracture; Fracture

  DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BARIATRIC ROLLATOR. WE HAVE NOT BEEN ABLE TO RETRIEVE THE DEVICE FOR EVALUATION. THE END-USER WAS SITTING ON THE DEVICE ON HIS PATIO. THE FRONT FORK REPORTEDLY GAVE WAY. HE SLID OUT OF THE DEVICE AND FELL HITTING HIS HEAD. THE DEVICE WAS STORED OUTSIDE OR IN THE TRUNK OF THE CAR. DEVICE WEIGHT CAP IS 500LBS.

  Patient problems: Fall

  MAUDE report 10397475 ↗