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Ki Catalyst 5Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850013379026), received between Dec 22, 2022 and Mar 15, 2023 — classified as 1 injury, 1 malfunction.

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

Device problems

  • Insufficient Device Problem Information2

Patient problems

  • Bruise/Contusion1
  • Limb Fracture1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    A COMPLAINT WAS REPORTED TO KI MOBILITY ON (B)(6) 2023 STATING THAT A RIGHT SIDE NUT FOR THE CASTER HOUSING FELL OUT WHILE THE END USER WAS TRAVELING OVER A THRESHOLD IN THE ASSISTED LIVING FACILITY THE END USER LIVES AT. THE COMPLAINT RECEIVED STATED THE FOLLOWING, "END USER IS VERY ACTIVE AND HITS THRESHOLDS PRETTY HARD IN THE HOME THEY LIVE IN. THE END USER HIT THE THRESHOLD GOING INTO THE RESTROOM AND THE BOLT FELL OUT CAUSING THE CASTER HOUSING TO BREAK LOOSE. THE END USER FELL TO THE FLOOR. WAS SEEN BY A DOCTOR AND IS OKAY WITH ONLY A BUMP AND A BRUISE. THE FACILITY SAYS THEY HAVE NOT PROVIDED THE CHAIR MAINTENANCE TO CHECK TO SEE HOW LONG THE SCREWS HAVE BEEN LOOSE. THE INCIDENT TOOK PLACE IN AN ASSISTED LIVING HOME."

    Patient problems: Bruise/Contusion

    MAUDE report 16545846 ↗
  • InjuryDec 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    USER IS UNHAPPY WITH THE CHAIR IN GENERAL AND RECENTLY FELL OUT OF THE CHAIR WHEN TRANSFERRING CAUSING HER TO BREAK HER FEMUR. ACCIDENT HAPPENED IN JANUARY AND SPENT SOME TIME IN HOSPITAL. ONCE DEALER RECEIVED THE CHAIR FOR EVALUATION, (B)(6) ASKED THEM NOT TO DO ANYTHING WITH THE CHAIR UNTIL HE COULD LOOK AT IT. NO PARTS/ACTION TO BE TAKEN AT THIS TIME.

    Patient problems: Limb Fracture

    MAUDE report 16034178 ↗

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.