Mallinckrodt 96370Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521157460), received between Dec 6, 2017 and Dec 6, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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. 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.

• MalfunctionDec 6, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NASAL TRACHEAL TUBE DESPITE THE MAXIMUM VOLUME OF INFLATION WAS INSUFFICIENT TO PREVENT "AIR REFLUX". THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088208 ↗
• MalfunctionDec 6, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE NASAL TRACHEAL TUBE PRESENTED A PUNCTURED CUFF. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088180 ↗