DAR 610U5257Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522039314), received between Jan 17, 2023 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 28, 2026Break; Obstruction of Flow

  Patient in CTICU "[cardio-thoracic intensive care unit]" underwent bedside percutaneous tracheostomy. The ventilator was plugged into bronch adapter (Covidien DAR connector, REF 610U5257, LOT 25G0004FAX, Exp 7/1/2030) during procedure. Once tracheostomy tube was inserted, we attempted to disconnect vent circuit from the bronch adapter, but the bronch adapter broke off into the vent circuit and could not be removed. Patient was bagged with BVM "[bag-valve-mask]" without any complication and RT "[respiratory therapist]" got new vent circuit. No harm met the patient, but this was a device failure causing obstruction of ventilator tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914753 ↗
• InjuryJan 17, 2023Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE IN THE PATIENT'S AIRWAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16184074 ↗