Mallinckrodt 125041Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522008765), received between Apr 19, 2017 and Sep 8, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THE CUFF ON THE ENDO BRONCHIAL TUBE WOULD NOT DEFLATE. CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6851732 ↗
• MalfunctionJun 13, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING PRETEST, THE CUFF WOULD NOT COMPLETELY DEFLATE. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6637050 ↗
• MalfunctionApr 19, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE PILOT VALVE ON THE ENDOBRONCHIAL TUBE DEFLATED. THE CUSTOMER STATED THAT IT WAS FOUND PRIOR TO USE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT. MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6506417 ↗