Mallinckrodt 126037 (UDI 30884522028961)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30884522028961), received between Apr 19, 2017 and Sep 17, 2019 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE TWO DEVICES' CUFF WAS FOUND DAMAGED WHEN EXAMINED BEFORE INTUBATION.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9079924 ↗
• MalfunctionSep 17, 2019Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE TWO DEVICES' CUFF WAS FOUND DAMAGED WHEN EXAMINED BEFORE INTUBATION.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9079917 ↗
• MalfunctionSep 19, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, WHILE CHECKING THE CUFF, THE CUFF DID NOT DEFLATE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6876169 ↗
• MalfunctionApr 19, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THE CUFF ON THE TRACHEOSTOMY TUBE DID NOT DEFLATE. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6506454 ↗