DRIVEMEDICAL K320DDA-SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00822383123370), received between Aug 17, 2020 and Mar 12, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY AN ATTORNEY ALLEGING THE RIGHT REAR WHEEL FELL OFF WHILE IN USE. THE END USER FELL AND RECEIVED BRUISES. THE END USER'S WIFE PUSHING THE WHEELCHAIR FELL AND BROKE HER LEG WHICH REQUIRED SURGERY. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, THE WHEEL ON THE LEFT REAR SIDE HAD BROKEN AROUND THE AXLE, PREVENTING THE WHEEL FROM STAYING ON THE AXLE ATTACHED TO THE WHEELCHAIR FRAME. PRODUCT LABELING STATES, "LARGE REAR WHEELS SHOULD BE INSPECTED AT LEAST ONCE A MONTH TO ENSURE PROPER TIGHTNESS. IF WHEEL WOBBLES OR IS LOOSE, RELEASE LOCK NUT AND TIGHTEN AXLE BOLT SLIGHTLY. TEST FOR PROPER TIGHTNESS BY LEANING CHAIR TO ONE SIDE AND SPIN ADJUSTED WHEEL." DRIVE DEVILBISS HEALTHCARE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION AND WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Limb Fracture

  MAUDE report 21586185 ↗
• InjurySep 20, 2021Sharp Edges; Sharp Edges

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. WHILE IN USE THE LEFT SIDE ARM PAD CUT HIM. THE END-USER STATES THAT THERE IS NO WEAR TO THE ARM PAD ITSELF BUT THERE'S A SHARP PIECE STICKING UP THROUGH THE CENTER OF THE PAD ABOUT 2 ¿" FROM THE FRONT. NO ADDITIONAL INFORMATION IS AVAILABLE. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION.

  Patient problems: Laceration(s)

  MAUDE report 12495003 ↗
• InjuryDec 15, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. THE UNIT IS BEING RETURNED FOR EVALUATION WHICH IS DELAYED DUE TO COVID-19 RELATED ISSUES. END-USER WAS GIVEN THE CHAIR AFTER KNEE SURGERY. SHE USED THE UNIT FOR APPROXIMATELY 2 MONTHS. THE WHEEL LOCK ON THE LEFT SIDE WAS LOOSE. THE UNIT TO SLIDE FROM UNDER HER AND SHE FELL. THE SERVICE PROVIDER SENT REPS TO TIGHTENED THE WHEEL LOCK/BRAKE AND REPLACED THE FOOT PEDAL BECAUSE IT BROKE. IT BECAME LOOSE AGAIN. SHE REPORTEDLY FELL THREE TO FOUR TIMES WHILE USING THE UNIT ONCE LANDING ON HER BACKSIDE, ONCE ON HER FACE. SHE BRUISED HER FOREHEAD AND BUSTED HER LIP... THE FIRST TIME SHE LANDED ON HER BUTT. THE SECOND TIME SHE FELL SHE HIT HER HEAD AND BRUISED HER FOREHEAD. BUSTED HER LIP. SHE FOUND LITTLE BLACK WASHERS ON THE FLOOR AND A THIN WIRE. SHE DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 11008009 ↗
• InjuryDec 9, 2020Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. WE WERE UNABLE TO RETRIEVE THE UNIT FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. END-USER WAS TRANSFERRING FROM HIS VEHICLE TO THE WHEELCHAIR WHEN THE BRAKES SLIPPED. THE END-USER FELL OUT OF THE CHAIR AND HIT HIS TRUCK. HE TORE A LIGAMENT IN HIS KNEE. HE HAD SURGERY TO REPAIR THE DAMAGE.

  Patient problems: Damage to Ligament(s); Fall

  MAUDE report 10976552 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  DRIVE DEVILBISS HEALTHCARE IS AN INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. WE HAVE NOT RECEIVED THE PRODUCT BACK FOR EVALUATION. THE SEAT BELT IS UNKNOWN, NOT AN ACCESSORY OF THE DEVICE. THE SEATBELT ON THE WHEELCHAIR DID NOT LOCK PROPERLY AND THE END USER FELL OUT. SHE FRACTURED SHOULDER AND SURGERY WAS REQUIRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10418303 ↗