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Drive 790Recalls & reported problems

Drive Devilbiss Healthcare · Steerable Knee Walker,1/ea · Class 1

Adverse event reports
10
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00822383183589), received between Nov 13, 2018 and Jun 9, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Adverse Event Without Identified Device or Use Problem2
  • Solder Joint Fracture2
  • Device Slipped1
  • Fracture1
  • Mechanical Problem1

Patient problems

  • Fall4
  • Laceration(s)3
  • Muscle/Tendon Damage2
  • Bone Fracture(s)1
  • Bruise/Contusion1
  • Head Injury1
  • Pain1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 2026Break

    DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING A KNEE WALKER BY THE END USER, WHO STATED THAT THE SEAT POST BROKE DURING USE CAUSING HER TO FALL. THE END USER CUT THE BACK OF HER LEFT THIGH ON THE BROKEN SEAT POST AND SUBSEQUENTLY RECEIVED SEVEN STITCHES. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE MEDICAL WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Patient problems: Laceration(s)

    MAUDE report 25443268 ↗
  • InjuryNov 11, 2025Mechanical Problem; Mechanical Problem

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A KNEE WALKER BY AN ATTORNEY LETTER ALLEGING THAT WHILE IN USE BY THE END USER, THE "HANDLEBARS DROPPED AND/OR COLLAPSED CAUSING HER TO LOSE BALANCE FALL AND SUSTAIN SERIOUS INJURIES AND DAMAGES," WHICH ARE ALLEGED TO INCLUDE A RIGHT ACHILLES TENDON RUPTURE AND "CHRONIC" REGIONAL PAIN SYNDROME. DRIVE IS ATTEMPTING TO INVESTIGATE THE INCIDENT THROUGH COOPERATION WITH THE END USER'S ATTORNEY.

    Patient problems: Muscle/Tendon Damage

    MAUDE report 23522602 ↗
  • InjuryJun 7, 2021Break; Break

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. WE HAVE NOT BEEN ABLE TO RETRIEVE THE DEVICE FOR EVALUATION. WE DO NOT HAVE COMPLETE DETAILS OF THE ENVIRONMENT IN WHICH THE DEVICE WAS USED. THE IFU WARNS AGAINST USE IN UNEVEN TERRAIN. WE ARE FILING THIS REPORT TO BE TIMELY. IT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS AVAILABLE. END-USER REPORTED THAT AS SHE WAS USING THE KNEE WALKER ON THE SIDEWALK OUTSIDE HER HOME WHEN THE UNIT BROKE. SHE FELL HITTING HER KNEE ON THE CEMENT SIDEWALK AND BRUISED HER KNEE BADLY. SHE WENT TO THE ER WHERE TREATMENT RECEIVED. SHE IS UNDER THE CARE OF AN ORTHOPEDIC SURGEON AS A RESULT OF THE INCIDENT.

    Patient problems: Bruise/Contusion; Fall

    MAUDE report 11952098 ↗
  • InjuryApr 7, 2021Solder Joint Fracture; Solder Joint Fracture

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. THE UNIT WAS NOT RETURNED TO DRIVE FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE END USER RENTED A KNEE WALKER IN THE COURSE OF HIS RECOVERY FROM A LEFT TIBIA AND FIBULA FRACTURE THAT HAD REQUIRED SURGERY. HE FELL ON HIS RIGHT SIDE WHEN THE SEAT POST SNAPPED DURING USE. AS PER MRI RESULTS, HE SUFFERED A RETRACTED TEAR OF THE RIGHT LONG HEAD BICEP TENDON AND A LIKELY PARTIAL TEAR OF THE RIGHT ROTATOR CUFF.

    Patient problems: Muscle/Tendon Damage

    MAUDE report 11631596 ↗
  • InjuryMay 11, 2020Solder Joint Fracture; Solder Joint Fracture

    DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. THIS REPORT IS BEING TENDERED IN AN OVERABUNDANCE OF CAUTION IN RESPONSE TO AN MDR REGRESSION ANALYSIS. THE DEVICE'S SEAT POST FAILED WHICH CAUSED THE CUSTOMER TO FALL. SHE HIT HER HEAD AND RECEIVED A MINOR CONCUSSION. SINCE THIS INCIDENT A DESIGN CHANGE UNDER PC#297 (2016/2017) HAS ADDRESSED THE SEAT POST ISSUE. THE SERIAL NUMBER PROVIDED SHOWS THAT THE UNIT WAS MANUFACTURED IN 2013, PRIOR TO THE CHANGES.

    Patient problems: Fall; Head Injury

    MAUDE report 10043976 ↗
  • InjuryFeb 5, 2020Device Slipped; Device Slipped

    DRIVE DEVILBIS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. THE UNIT HAS NOT BEEN RECOVERED FOR EVALUATION. END-USER WAS RECOVERING FROM LEFT ANKLE ACHILLES SURGERY. HE IS A "TALL, BIG GUY". ON THE SECOND DAY THE DEVICE SLID OUT FROM UNDER THE USER. HE FELL AND LANDED ON HIS RIGHT LEG, HE WAS DIAGNOSED WITH A FRACTURED/DISLOCATED MY ANKLE AND BROKE TIBIA WHICH REQUIRED SURGERY. PATIENT WAS TREATED IN A NURSING HOME FOR 4 MONTHS. HANDLE HEIGHT ON PRODUCT IS 3.0875 FEET. PRODUCT IS DISCONTINUED.

    Patient problems: Bone Fracture(s)

    MAUDE report 9673461 ↗
  • InjuryJan 17, 2020Fracture; Fracture

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. THE END-USER WAS UTILIZING THE DEVICE THROUGHOUT HIS RECUPERATION FROM ACHILLES TENDON SURGERY. HE WAS WALKING IN THE PARK AIDED BY THE KNEE WALKER WHEN THE RIGHT HAND BRAKE SNAPPED. HE FELL TO THE PAVEMENT AND REINJURED HIS ACHILLES TENDON ON HIS LEFT SIDE.

    Patient problems: Fall; Pain

    MAUDE report 9603850 ↗
  • InjuryAug 22, 2019Adverse 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 KNEE WALKER. DRIVE DOES NOT EXPECT TO RECEIVE THE PRODUCT FOR EVALUATION. END-USER IS 6"5" AND HAS JUST UNDERGONE SURGERY FOR A RUPTURED ACHILLES TENDON. HE HAS HAD TWO (2) SERIOUS FALLS USING THE DEVICE. HE HAD HIT ROCKS IN THE ROAD OR JOINTS IN THE CONCRETE AND HAS GONE OVER THE HANDLE BARS WITH THE MOMENTUM OF MOVEMENT. THE SECOND FALL CAUSED LACERATIONS. HIS WIFE PICKED UP THE UNIT. INSTRUCTIONS FOR USE CAUTION AGAINST TRAVERSING CRACKS IN THE ROAD AND LOOSE GRAVEL. MAXIMUM HEIGHT OF THE HANDLE BAR IS 3 FEET.

    Patient problems: Laceration(s)

    MAUDE report 8922837 ↗
  • InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. IT WAS OBTAINED FROM A SERVICE PROVIDER. WE WERE NOTIFIED OF THE INCIDENT UPON RECEIPT OF LEGAL DOCUMENTATION. WE HAVE NO ACCESS TO THE DEVICE FOR EVALUATION. WE WILL UPDATE THIS SUBMISSION WHEN MORE DATA BECOMES AVAILABLE. WE ARE FILING IN AN OVERABUNDANCE OF CAUTION. THE END-USER RECEIVED THE KNEE WALKER AND IT REPORTEDLY BROKE THE SAME DAY. WE DO NOT KNOW THE SPECIFICS OF THE INCIDENT OR THE INJURY.

    Patient problems: Fall

    MAUDE report 8827235 ↗
  • InjuryNov 13, 2018Break; Break

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A KNEE WALKER. (B)(4) WAS NOTIFIED OF THE INCIDENT THROUGH AN ATTORNEY'S LETTER. THE UNIT WAS RENTED BY THE END-USER. IT HAD BEEN PREVIOUSLY RENTED 9 OTHER TIMES FOR A TOTAL USAGE OF 279 DAYS. END-USER WAS USING THE UNIT WHEN THE SEAT POST REPORTEDLY SNAPPED AND CUT HER INNER THIGH. WE HAVE NO ADDITIONAL INFORMATION. WE WILL FILE A FOLLOW-UP REPORT WHEN AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Patient problems: Laceration(s)

    MAUDE report 8066650 ↗

Other WALKER, MECHANICAL devices

All WALKER, MECHANICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.