MEDLINE K3186N34SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10193489083699), received between May 18, 2026 and Sep 28, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component; Damaged Thread

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924327 ↗
• MalfunctionSep 24, 2026Fracture

  It was reported that "THE TWO BIG WHEELS ARE BROKEN.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884639 ↗
• MalfunctionAug 11, 2026Crack

  It was reported that "The right footrest got loose and then it came off/ broke off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215227 ↗
• MalfunctionAug 11, 2026Material Separation

  It was reported that rear right rubber tire came off. Customer was going on a walk with wheelchair when rubber came off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212265 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  It was reported that "the wheelchair has wheel damaged".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183501 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  It was reported that right armrest is falling to the ground. Need a replacement right armrest.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181320 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  It was reported that the rubber of the Right wheel came off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158133 ↗
• MalfunctionAug 5, 2026Fracture

  It was reported that the wheelchair arrived fractured; the left big back wheel and axle are fractured and therefore cannot move and it is making loud creaking noise and it bent the frame.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145247 ↗
• MalfunctionMay 18, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE WHEELCHAIR WAS RECEIVED WITH BENT HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208110 ↗