Guardian K4166N24SRecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K4, 16", SB DDLA, SA FOOT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00193489099686), received between Sep 17, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938013 ↗MalfunctionSep 17, 2026Fracture
It was reported that the device had a "cracked wheel frame."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801828 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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