Guardian K4166N24ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193489099679), received between May 27, 2026 and Aug 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  It was reported that the rear wheel broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201576 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2026 WHILE SEATED IN THE DEVICE AND ATTEMPTING TO PUT ON A "COMPRESSION SOCK," THE WHEEL "CAME OFF" AND THE INDIVIDUAL FELL TO THE FLOOR. THE CUSTOMER ALSO REPORTED THAT "PART OF THE WHEELCHAIR COLLAPSED ONTO" THE USER'S LEFT FOOT.

  Patient problems: Fall; Limb Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 25302631 ↗