Mallinckrodt 125035Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 30884522008734), received between Mar 24, 2017 and Oct 21, 2019 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (25 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT BALLOON WAS MISSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9216471 ↗
• MalfunctionOct 14, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD POOR CUFF AND ONLY ONE SIDE BULGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9189337 ↗
• MalfunctionOct 14, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD NO TRACHEAL BALLOONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9186922 ↗
• MalfunctionOct 14, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT AIR DID NOT LEFT OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9186079 ↗
• MalfunctionJun 28, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8742880 ↗
• MalfunctionApr 5, 2018Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS NOT DEFLATED PROPERLY DURING THE CUFF TEST. IT REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7401267 ↗
• MalfunctionFeb 23, 2018Deflation Problem; Deflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE AN A PATIENT, THE UNIT'S CUFF COULD NOT BE DEFLATED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7292073 ↗
• MalfunctionFeb 15, 2018Deflation Problem; Deflation Problem

  ACCORDING TO THE REPORTER, DURING CUFF CHECK PRIOR TO USE ON A PATIENT, DEFLATION FAILURE WAS CONFIRMED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7273567 ↗
• MalfunctionDec 7, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 7097007 ↗
• MalfunctionNov 22, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE, DURING INSPECTION, THE CUFF OF AN ENDOBRONCHIAL TUBE COULD NOT BE DEFLATED COMPLETELY. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THE SAMPLE IS EXPECTED TO BE RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 7054103 ↗
• MalfunctionNov 22, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUSTOMER THAT COULD TAKE OUT THE AIR FROM THE BALLOON. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7053518 ↗
• MalfunctionNov 13, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING AN ENDOBRONCHIAL TUBE IN WHICH THE TRACHEAL CUFF WOULD NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7026470 ↗
• MalfunctionNov 13, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING AN ENDOBRONCHIAL TUBE IN WHICH THE TRACHEAL CUFF WOULD NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7026463 ↗
• MalfunctionNov 13, 2017Deflation Problem; Deflation Problem

  RECEIVED A COMMUNICATION REGARDING AN ENDOBRONCHIAL TUBE IN WHICH THE TRACHEAL CUFF WOULD NOT DEFLATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT. RECEIVED NOTIFICATION OF A TRACHEAL CUFF THAT DID NOT DEFLATE COMPLETELY DURING CUFF TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7026455 ↗
• MalfunctionOct 5, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PRE-TEST THE CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6915773 ↗
• MalfunctionOct 5, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PRETEST THE CUFF COULD NO BE DEFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6915576 ↗
• MalfunctionOct 5, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECIEVED A REPORT THAT DURING THE CUFF TEST, AIR LEAKED FROM THE AIR INLET.

  Patient problems: No Patient Involvement

  MAUDE report 6914908 ↗
• MalfunctionOct 4, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PRE-TEST THE TUBE'S CUFF WOULD NOT DEFLATE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6914474 ↗
• InjurySep 13, 2017Deflation Problem; Deflation Problem

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

  Patient problems: Extubate

  MAUDE report 6862523 ↗
• MalfunctionSep 12, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING A CUFF CHECK A LEAK WAS FOUND. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6859026 ↗
• MalfunctionAug 24, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6819387 ↗
• MalfunctionAug 24, 2017Deflation Problem; Deflation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6819383 ↗
• MalfunctionJul 26, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT WHILE IN USE ON A PATIENT, AFTER 3 HOURS, THE CUFF WOULD NOT DEFLATE. THE CUFF WAS PRE-TESTED PRIOR TO USE. RECANNULATION OF A REPLACEMENT TUBE WAS NOT REQUIRED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745998 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED A COMMUNICATION THAT THE BLUE TUBE (BRONCHIAL) AND THE TRANSPARENT TUBE (TRACHEAL) WERE FOUND ADHERED ALTERNATIVELY.

  Patient problems: Extubate

  MAUDE report 6734829 ↗
• MalfunctionJul 17, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE, DURING INSPECTION, THE CUFF OF AN ENDOBRONCHIAL TUBE COULD NOT BE DEFLATED COMPLETELY. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THE SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6717263 ↗