DRIVEMEDICAL K318DDA-SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822383123356), received between Sep 13, 2021 and Jul 23, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY A HEALTHCARE FACILITY OF AN INCIDENT INVOLVING A WHEELCHAIR. THE FACILITY REPORTED THAT THE BACK UPHOLSTERY OF THE WHEELCHAIR RIPPED DURING USE, CAUSING THE END USER TO FALL FROM THE CHAIR. AS A RESULT OF THE FALL, THE END USER WAS TRANSPORTED TO A HOSPITAL WHERE A CT SCAN CONFIRMED A CONCUSSION. 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 22577785 ↗
• InjuryDec 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY AN END USER, WHO STATED THAT THE WHEELCHAIR TIPPED OVER BACKWARDS AND CAUSED A HEAD INJURY. 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 16042916 ↗
• InjuryDec 29, 2021Solder Joint Fracture; Solder Joint Fracture

  DRIVE RECEIVED A REPORT THAT THE END USER OF A TRANSPORT CHAIR WAS INJURED WHEN THE DEVICE [?]S SIDE FRAME WELD BROKE ABOVE FOOTREST HANGERS THE END-USER "HIT HER FACE ON THE WALL AND SUSTAINED BRUISES UNDER HER EYE AND THEN FELL AND HIT BACK OF HEAD ON THE FLOOR." THE REPORTER STATED THAT THE END USER DID NOT SEEK MEDICAL ATTENTION BUT SELF-MEDICATED WITH TYLENOL FOR THE SORENESS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Easy Bruising; Fall

  MAUDE report 13111646 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP IF ADDITIONAL DATA BECOMES AVAILABLE. THE END-USER WAS A RESIDENT OF HOSPICE CARE. WHILE SITTING IN THE CHAIR THE USER'S LEG WAS LACERATED BY THE CASTER BOLT. THE CAREGIVER AND NURSE BANDAGED AND REDRESSED THE WOUND. THE END-USER PASSES AWAY FROM THE INFIRMARY THAT CAUSED HER TO BE A HOSPICE RESIDENT.

  Patient problems: Laceration(s)

  MAUDE report 12464512 ↗