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Ki Catalyst 5VxRecalls & reported problems

Ki Mobility, LLC · CATALYST 5VX MANUAL WHEELCHAIR · Class 1

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850013379033), received between Jul 11, 2024 and Feb 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 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: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem3
  • Use of Device Problem2
  • Damaged Thread1
  • Naturally Worn1
  • Patient Device Interaction Problem1

Patient problems

  • Bone Fracture(s)4
  • Insufficient Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 18, 2026Naturally Worn; Damaged Thread

    WHEEL LOCK DISENGAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE ONE OF THE WHEEL LOCK BOLTS WORKED ITS WAY OUT. BRAKE BOLT WORKED ITS WAY OUT WHILE HUSBAND WAS TRYING TO MOVE CLIENT FROM CHAIR TO BED. HUSBAND WENT TO SEAT PATIENT IN CHAIR TO GET A BETTER HOLD THEN WHEEL LOCK DISENGAGED AND CHAIR ROLLED AWAY. BOTH PATIENT AND HUSBAND FELL TO FLOOR. PATIENT COMPLAINED OF DISCOMFORT IN LEGS. END USER WAS TAKEN TO GET AN MRI WHERE THEY DISCOVERED HER LEG WAS BROKEN. END USER DID NOT COMPLAIN OF ANY PAIN/INJURY. ON 11/25 USER WENT TO PT APPOINTMENT, IT WAS SUGGUESTED THAT USER GET X-RAYS, AND THAT SHOWED BOTH LEGS TO BE FRACTURED.

    Patient problems: Bone Fracture(s)

    MAUDE report 24382098 ↗
  • MalfunctionFeb 18, 2026Mechanical Problem; Patient Device Interaction Problem

    DEALER CLAIMS THAT THE END USER WAS TRANSFERRING OUT OF THE CHAIR AND THE ARMREST RECEIVER FELL OUT AND THE END USER FELL AND BROKE 2 RIBS. DEALER STATED THAT THEY HAD BEEN OUT 5 TIMES FOR MAINTENANCE AND TIGHTENED THE HARDWARE FOR THE ARMREST RECEIVERS. IT HAPPENED ON 10/24 AT THE END USER'S HOME.

    Patient problems: Bone Fracture(s)

    MAUDE report 24381745 ↗
  • MalfunctionDec 20, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

    WHEEL LOCK DISEGNAGED DURING PATIENT TRANSFER FROM CHAIR TO BED BECAUSE SOME OF THE BOLTS/HARDWARE WORKED IT'S WAY OUT. BRAKE BOLT WORKED IT'S WAY OUT WHILE HUSBAND WAS TRYING TO MOVE USER FROM CHAIR TO BED. HUSBAND SEATED USER IN CHAIR TO GET A BETTER HOLD OF WHEEL LOCK. THEN WHEEL LOCK DISENGAGED, AND CHAIR ROLLED AWAY.

    Patient problems: Bone Fracture(s)

    MAUDE report 20988767 ↗
  • MalfunctionAug 6, 2024Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE FORK/STEM ASSEMBLY CAME OUT OF THE HOUSING WHILE THE END USER WAS IN THE CHAIR, CAUSING HIM TO FALL OUT. IT APPEARS THE CASTER HOUSING IS MISSING A COMPONENT PER THE PHOTO FURNISHED TO US. THAT COMPONENT WAS PRESENT AT TIME OF FINAL INSPECTION PRIOR TO SHIPPING. THIS APPEARS TO BE EVIDENCE OF IMPROPER SERVICING. THE HOUSING MAY HAVE ALLOWED THE FORK/STEM TO FALL OUT. THE CHAIR HAS NOT BEEN MADE AVAILABLE FOR INSPECTION.

    Patient problems: Insufficient Information

    MAUDE report 19918760 ↗
  • MalfunctionJul 11, 2024Use of Device Problem; Use of Device Problem

    END USER STATED THEY LOST THE HARDWARE FOR THE CASTER HOUSING AND PERFORMED HOME REPAIR. END USER DID NOT NOTIFY DEALER OF PROBLEM. IT IS UNKNOWN HOW LONG THE WHEELCHAIR WAS IN USE BEFORE CASTER FELL OFF. IT'S UNKNOWN AS TO WHETHER PROPER MAINTENANCE WAS PERFORMED.

    Patient problems: Bone Fracture(s)

    MAUDE report 19724676 ↗

Other Wheelchair, Mechanical devices

All Wheelchair, Mechanical devices →

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