Guardian KPD4N22S1Recalls & reported problems
Medline Industries, Inc. · WHEELCHAIR,PEDIATRIC +,14,SB-DLA,SA · Class 1
All models of Guardian (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193489037657), received between Jun 4, 2026 and Jun 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Mechanics Altered
IT WAS REPORTED THAT "THE RIGHT TELESCOPING HANDLE NO LONGER LOCKS INTO PLACE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25394733 ↗
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 K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Guardian K3206N24SMedline 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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