Mallinckrodt 18770Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 50884522007595), received between Apr 6, 2017 and Aug 13, 2019 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TUBE HAD CUFF INFLATION/DEFLATION ISSUE. REINTUBATION WAS REQUIRED.

  Patient problems: Extubate; No Information

  MAUDE report 8891241 ↗
• InjuryAug 5, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE ELEVEN TUBES DEFLATED IN A SHORT PERIOD. IT WAS REPORTED THAT THE TUBE LOST PRESSURE AFTER 2 TO 3 DAYS ON AVERAGE AND WAS TESTED WITH CUFOMETER WITH PRESSURE NOT STABLE. AFTER TAKING OUT OF THE PATIENT, THE TUBE WAS TESTED AND THERE WAS NO LEAKAGE IN THE CUFF. REINTUBATION WAS REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: No Information

  MAUDE report 8858772 ↗
• MalfunctionAug 4, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT VALVE OF THE ELEVEN TUBES DEFLATED IN A SHORT PERIOD. IT WAS REPORTED THAT THE TUBE LOST PRESSURE AFTER 2 TO 3 DAYS ON AVERAGE AND WAS TESTED WITH CUFOMETER WITH PRESSURE NOT STABLE. AFTER TAKING OUT OF THE PATIENT, THE TUBE WAS TESTED AND THERE WAS NO LEAKAGE IN THE CUFF. REINTUBATION WAS REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: No Information

  MAUDE report 8858467 ↗
• MalfunctionNov 9, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE ONE-WAY VALVE LEAKED DURING OPERATION. THE CUSTOMER ALSO REPORTED THAT BECAUSE IT CANNOT BE CHANGED DURING OPERATION, THE VALVE WAS CLAMPED TO PREVENT AIR LEAKAGE. IT WAS THEN INDICATED THAT AFTER THE OPERATION, THE AIR BAG WAS TESTED AND IT WAS BROKEN, SO IT PROVED THAT THE VALVE WAS THE SOURCE OF THE AIR LEAKAGE. THE CUSTOMER ALSO STATED THE IS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8054484 ↗
• InjuryAug 23, 2018Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS SUSPECTED CRACKED. IT WAS STATED THAT THE SPUTUM OF THE PATIENT WAS CAUGHT FROM THE PILOT BALLOON THAT CAUSE OF THE ISSUE. THE CUSTOMER INDICATED THAT THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 7809239 ↗
• MalfunctionJul 30, 2018Material Discolored

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TUBING WAS YELLOWISH. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7731503 ↗
• MalfunctionApr 6, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON INFLATING THE CUFF, AIR LEAKED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7405207 ↗
• MalfunctionApr 6, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INFLATED CUFFED LEAKED THE AIR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7405204 ↗
• MalfunctionApr 6, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INFLATED CUFFED LEAKED THE AIR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7405203 ↗
• MalfunctionJan 18, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE CUFF TEST, THE INFLATED CUFF LEAKED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7203798 ↗
• MalfunctionJan 10, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE CUFF TEST, IT WAS FOUND THAT THE CUFF LEAK THE AIR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7180483 ↗
• MalfunctionOct 4, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6914158 ↗
• MalfunctionAug 29, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE CUFF CHECK PRIOR TO PATIENT USE, A CUFF FAILURE WAS OBSERVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6828150 ↗
• MalfunctionApr 6, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE CUFF ON THE TRACHEAL TUBE WOULD NOT INFLATE. CUSTOMER INDICATED THE ISSUE WAS FOUND PRIOR TO PATIENT USE.

  Patient problems: No Patient Involvement

  MAUDE report 6462845 ↗