Mallinckrodt 126035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522028954), received between Jun 28, 2017 and Nov 5, 2018 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionNov 5, 2018Component Missing; Component Missing

  ACCORDING TO THE REPORTER, THE DEVICE HAD INCORRECT COMPONENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 8039266 ↗
• InjuryDec 7, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT WHILE IN USE ON A PATIENT, THE CUFF DID NOT DEFLATE. THE CUSTOMER REPORTED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7098010 ↗
• InjuryJun 28, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT AN ENDOBRONCHIAL TUBE FAILED TO INFLATE OR DEFLATE. IT WAS REPORTED THAT A SECOND DEVICE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6676062 ↗