MEDLINE K3186N44ERecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K3, 18", SB HARFLA, ELR FOOT · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193489088215), received between May 27, 2026 and Sep 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936097 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934440 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922115 ↗MalfunctionSep 28, 2026Material Twisted/Bent
It was reported that the unit arrived with bent handles.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914829 ↗MalfunctionSep 25, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906201 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT THE WHEELCHAIR WAS DELIVERED WITH A BROKEN FRONT WHEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299101 ↗
Other Wheelchair, mechanical devices
- MEDLINE K1186N22SMedline Industries, Inc. · Wheelchair, mechanical48 reports
- Guardian K4186N24EMedline Industries, Inc. · Wheelchair, mechanical22 reports
- MEDLINE INDUSTRIES, INC. MDS808650Medline Industries, Inc. · Wheelchair, mechanical18 reports
- Medline MDS806850Medline Industries, Inc. · Wheelchair, mechanical17 reports
- Guardian K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- MEDLINE K3186N34SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.