Mallinckrodt 125039Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30884522008758), received between May 30, 2017 and Jan 18, 2018 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2018Deflation Problem; Deflation Problem

  ACCORDING TO THE REPORTER, DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WOULD NOT DEFLATE COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7203738 ↗
• InjuryOct 11, 2017Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING A BRONCHOSCOPE GETTING STUCK IN BRONCHO-CATH TUBE. IT WAS ALLEGED THAT THE BRONCHO-CATH TUBE MALFUNCTIONED AND CUSTOMER HAD TO REPLACE THE PATIENT TUBE. IT WAS REPORTED THAT THEY USED A NON-MEDTRONIC BRONCHOSCOPE. IT WAS INDICATED THAT THERE WAS NO FURTHER PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 6942718 ↗
• MalfunctionOct 5, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PRE-TEST THE CUFF COULD NOT BE DEFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6915776 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827891 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827860 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827771 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827692 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827561 ↗
• MalfunctionAug 29, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6827535 ↗
• MalfunctionJul 26, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CUFF ON THE ENDOBRONCHIAL TUBE INFLATED, BUT WOULD NOT DEFLATE. THE CUFF NEEDED TO BE SQUEEZED TO DEFLATE. THE CUFF WAS TESTED PRIOR TO INTUBATION. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6746036 ↗
• MalfunctionJul 26, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CUFF ON THE ENDOBRONCHIAL TUBE INFLATED, BUT WOULD NOT DEFLATE. THE CUFF NEEDED TO BE SQUEEZED TO DEFLATE. THE CUFF WAS TESTED PRIOR TO INTUBATION. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6746031 ↗
• MalfunctionJun 28, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT WHERE IT WAS ALLEGED THAT DURING THE CUFF TEST, THE AIR FROM THE TRACHEAL BALLOON WAS NOT DEFLATED COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6675523 ↗
• MalfunctionJun 23, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6665503 ↗
• MalfunctionJun 23, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE ENDOBRONCHIAL TUBE'S TRACHEAL CUFF DIDN'T INFLATE COMPLETELY. THIS WAS IDENTIFIED DURING PRE-TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6664019 ↗
• MalfunctionMay 30, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6598330 ↗
• MalfunctionMay 30, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6598292 ↗