Guardian K3186N24ERecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K3, 18", SB DDLA, ELR FOOT · Class 1
All models of Guardian (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00193489087133), received between May 3, 2026 and Sep 30, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Activation Problem2
- Mechanical Problem2
- Loose or Intermittent Connection1
- Material Separation1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Fall1
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Activation Problem
It was reported that "The legrests will no longer lower to be stored. They are stuck in the up position.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945582 ↗MalfunctionSep 29, 2026Fracture
Patient problems: Fall; Pain
MAUDE report 50937686 ↗MalfunctionSep 29, 2026Fracture; Mechanical Problem
Customer states the armrests have stripped screws and the brakes are not holding on both sides.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936343 ↗MalfunctionSep 29, 2026Fracture; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933216 ↗MalfunctionSep 28, 2026Activation Problem
It was reported that the legrests are stuck in the upright position and cannot be lowered.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915838 ↗MalfunctionSep 25, 2026Loose or Intermittent Connection; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903037 ↗MalfunctionSep 17, 2026Fracture
It was reported that the footrest cracked.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803850 ↗MalfunctionAug 13, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241664 ↗MalfunctionMay 3, 2026No Apparent Adverse Event
THE CUSTOMER STATED "THE BACK WHEEL ARRIVED WITH A BROKEN SPOKE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062580 ↗MalfunctionMay 3, 2026Mechanical Problem
IT WAS REPORTED THAT THE WHEELCHAIR HAS A DEFECTIVE LEG REST, AND THE RELEASE MECHANISM FOR LOWERING THE LEG DOES NOT FUNCTION. THE CUSTOMER ALSO REPORTED A DAMAGED SPOKE AND A DISENGAGED HANDBRAKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062472 ↗
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
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE KX228V21EMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE K3186N34SMedline Industries, Inc. · Wheelchair, mechanical9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page