Ki Rogue 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850013379323), received between Jul 23, 2025 and Feb 3, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Use of Device Problem

  THE END USER WAS GOING DOWN A HILL AND LOST CONTROL AND HIT A BUMP AND WAS LAUNCHED FROM THE CHAIR. THE END USER HAD A FACIAL FRACTURE AND LOST SOME TEETH, SOME BRUISING, AND ABRASIONS TO HER HANDS. HOSPITALIZED FOR 3 DAYS WITH MONITORING AND X-RAYS DUE TO MOUTH TRAUMA.

  Patient problems: Abrasion

  MAUDE report 24248835 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DEALER CLAIMS THE BACK UPHOLSTERY BROKE AWAY FROM THE BACK TUBES AND 2 ATTACHING SCREWS ON THE TENSION ADJUSTABLE BACK UPHOLSTERY AND THE CLIENT FELL BACKWARD, HIT THE WALL AND BROKE THRU THE SHEET ROCK AND WAS UNCONSCIOUS, CLIENT WAS ON THE FLOOR FOR AN HOUR UNTIL PARENT CAME TO GET HIM. THE END USER WAS GOING FROM HALL WAY INTO HIS BEDROOM. AS HE WAS PROPELLING, PRESSURE WAS PUT ON THE BACK REST AND HE IS PARALYZED AND DID NOT FEEL THE UPHOLSTERY SLIDING DOWN.

  Patient problems: Loss of consciousness

  MAUDE report 23622082 ↗
• MalfunctionAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEALER STATES THAT THE CAMBER TUBE ASSEMBLY SNAPPED ON THE END USERS CHAIR WHILE IN THE CHAIR. HE WAS IN CHAIR GOING DOWN HIS HALLWAY WHEN THE CAMBER TUBE SNAPPED AND HE FELL OUT OF CHAIR INJURING HIS RIGHT INSIDE ELBLOW. HE WENT TO THE ER ON FRIDAY, (B)(6) 2025. INJURY REPORTED ON (B)(6) 2025.

  Patient problems: Bruise/Contusion; Swelling/ Edema

  MAUDE report 22921437 ↗
• MalfunctionJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE END USER WAS GOING UP A RAMP AND FELL BACK. END USER STATED SHE FELL BACK AND HIT HEAD ON CONCRETE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22576491 ↗