Mallinckrodt 125239Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30884522008796), received between Jul 21, 2017 and Jul 3, 2018 — classified as 2 malfunctions.

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

• MalfunctionJul 3, 2018Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, DURING INSPECTION PRIOR TO USE ON A PATIENT, THE CUFF WOULD NOT DEFLATE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7658192 ↗
• MalfunctionJul 21, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT PRIOR TO USE ON A PATIENT, THE TRACHEAL TUBE DEFLATED AFTER THE CUFF WAS INFLATED. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: Extubate

  MAUDE report 6734813 ↗