Guardian MDS868BTRBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00193489180605), received between Apr 23, 2026 and Sep 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture

  It was reported that ¿The seat has a bent crease in the middle due to the way this is being packaged.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947618 ↗
• MalfunctionSep 28, 2026Fracture

  It was reported that "the frame is fractured."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910656 ↗
• MalfunctionSep 24, 2026Fracture

  It was reported that "Translator has fractured at the weld left side when sitting in it."

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 50889534 ↗
• MalfunctionJul 1, 2026Fracture

  IT WAS REPORTED THAT THE FRAME BROKE WHILE CUSTOMER WAS MAKING A TURN ON THE SIDEWALK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679217 ↗
• MalfunctionJun 25, 2026Material Separation

  CUSTOMER STATED "THE WELD UNDER THE SEAT HAS BROKEN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623581 ↗
• MalfunctionMay 27, 2026Fracture

  IT WAS REPORTED THAT DURING USE, THE UPPER RIGHT BACK ROD BROKE IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299461 ↗
• MalfunctionMay 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE FRAME WAS DEFECTIVE AND BENT CAUSING THE WHEEL TO NOT GO STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195093 ↗
• MalfunctionApr 23, 2026Collapse; Defective Device

  IT WAS REPORTED THAT THE FRAME SNAPPED UPON SITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973996 ↗