EVO614HDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00606509100304), received between Jul 25, 2024 and Aug 6, 2026 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available

  Consumer alleges she does not believe she has the appropriate seating system for her unit and feels that she may require a different seat. She alleges that the current seat causes her to slide forward, preventing her from maintaining proper back support against the seat back. As a result, she alleges that she is experiencing back pain and that the sliding is contributing to pressure sores.

  Patient problems: Abrasion

  MAUDE report 50155829 ↗
• InjuryFeb 20, 2026Appropriate Device Problem Term/Code Not Available

  CONSUMER ALLEGES OVER THE PAST FIVE MONTHS, HE HAS EXPERIENCED MULTIPLE INCIDENTS WHERE THE UNIT UNEXPECTEDLY SHIFTS INTO FREEWHEEL MODE WHILE GOING DOWN HIS RAMP, CAUSING IT TO VEER TO THE RIGHT. AS A RESULT, HE HAS ALLEGEDLY FALLEN FROM THE CHAIR TWICE.

  Patient problems: Bruise/Contusion

  MAUDE report 24399787 ↗
• InjuryJan 15, 2026Appropriate Device Problem Term/Code Not Available

  CONSUMER ALLEGES HIS CHAIR PINNED HIM AGAINST A DOORWAY, CAUSING SEVERE INTERNAL AND EXTERNAL BLEEDING IN HIS LEG.

  Patient problems: Bruise/Contusion

  MAUDE report 24081626 ↗
• InjuryJul 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CONSUMER ALLEGES THE DRIVER OF BUS PUSHED HIM ON AND OFF BUS BUT WHEN HE DID THE DRIVER HIT THE SEAT OF THE UNIT ON THE SEATS ON THE BUS AND THAT IS WHEN THE DAMANGE INITALLY OCCURRED. SEAT WILL NOT STAY IN PLACE [?] TECH CAME DOWN TO CHECK UNIT. CONSUMER HAD ROPE TIED TO SEAT TO KEEP IT IN POSITION AND WHEN TECH TOOK IT OFF HE ALLEGEDLY DID NOT PUT IT ON TIGHT THE CONSUMER RAN INTO TOWEL RACK AND A FURNACE.

  Patient problems: Bruise/Contusion

  MAUDE report 22578197 ↗
• InjuryJan 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEALER CALLED STATING UNIT WAS INVOLVED IN A CAR ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168042 ↗
• InjuryOct 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CONSUMER ALLEGES SHE TIPPED OVER IN THE CHAIR AND THE CHAIR ALLEGEDLY LANDED ON TOP OF HER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559320 ↗
• InjuryJul 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CONSUMER ALLEGES WHEN UNIT IS ON LOWEST SPEED SETTING UNIT WILL ALLEGEDLY SPEED ALL THE WAY UP RANDOMLY AND UNCONTROLLABLY ALLEGEDLY CAUSING THE CONSUMER TO SMASH INTO A WALL.

  Patient problems: Laceration(s)

  MAUDE report 19827028 ↗