MEDLINE K3166N44E1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193489142924), received between May 8, 2026 and Sep 30, 2026 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture

  It was reported that "the right foot pedal is loose and continues to fall down when she tries to put her foot on it. She believes it may be stripped."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946559 ↗
• MalfunctionSep 28, 2026Fracture

  It was reported that "the plastic bit of the armrest that has broken".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913627 ↗
• MalfunctionMay 13, 2026Material Twisted/Bent

  THE CUSTOMER STATED THAT THAT THE FRAME OF THE CHAIR IS BENT PREVENTING THE CHAIR FROM UNFOLDING FULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165291 ↗
• MalfunctionMay 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE FRAME OF THE WHEELCHAIR WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129565 ↗