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Ki Catalyst 4Recalls & reported problems

Ki Mobility, LLC · CATALYST 4 MANUAL WHEELCHAIR · Class 1

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850013379019), received between Dec 20, 2022 and Apr 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component2

Patient problems

  • Bruise/Contusion1
  • Hematoma1

Recent adverse event reports

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

  • MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    A COMPLAINT WAS REPORTED ON (B)(6) 2023 STATING THAT THE DEALER CLAIMS THE RIGHT CASTER CAME OFF OF THE CHAIR DURING PROPULSION. THE END USER FELL DOWN WITH THE CHAIR AND SUFFERED MILD BRUISING AND PAIN. IT WAS FURTHER REPORTED THAT IT WAS THE RIGHT SIDE CASTER HOUSING BOLT AND ECCENTRIC NUT THAT HAD FELL OUT. "THE BOTTOM NUT (ECCENTRIC NUT?) AND BOLT ON THE CASTER ASSEMBLY FELL OFF AND CAUSED THE CASTER TO PIVOT AND THE CHAIR TIPPED OVER WITH THE PATIENT STILL IN THE CHAIR." NO FURTHER INFORMATION WAS OBTAINED.

    Patient problems: Bruise/Contusion

    MAUDE report 16775797 ↗
  • MalfunctionDec 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THERAPIST TOLD DEALER THAT USER WAS REACHING FORWARD FOR SOMETHING IN DINING ROOM, AND SAID THAT LEFT CASTER BOTTOM LEFT ECCENTRIC NUT WORKED ITSELF OUT, IT DOES NOT SEEM BROKEN PER DEALER. BOLT WAS BACKED HALF WAY OUT AND THE WASHER AND NUT WAS MISSING WHEN HE RECEIVED THE CHAIR. USER WAS TAKEN TO HOSPITAL AND DIAGNOSED WITH SUBDURAL HEMATOMA. (BUMP ON HEAD) RETURNED LAST NIGHT TO THE FACILITY. IN THE HOSPITAL NOTES PER THERAPIST, IT STATED NEURO SURGERY WAS CONSULTED AND NO PAIN IN HIS BACK, NO DISTRACTING INJURIES. CT WAS NEG FOR INJURY, HE HAS FULL RANGE OF MOTION AND THE CERVICAL COLLAR WAS CLEARED. CT OF THE HEAD SHOWED SMALL SUBDURAL HEMATOMA.

    Patient problems: Hematoma

    MAUDE report 16018249 ↗

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.