Mallinckrodt 18780Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 50884522007618), received between May 2, 2017 and Mar 8, 2022 — classified as 18 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (15 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BALLOON OF THE DEVICE WAS RUPTURED OR BURST WHEN TRIED INFLATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696482 ↗
• MalfunctionApr 2, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE AIR WAS NOT INJECTED ON THE DEVICE¿S CUFF DURING THE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9915117 ↗
• MalfunctionJan 8, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL INTUBATION DIAMETER OF THE PATIENT WAS 7.0 CM, AND THE ENDOTRACHEAL INTUBATION DIAMETER OF 8.0 CM WAS TO BE REPLACED FOR TRACHEOSTOMY. BEFORE REPLACING THE ENDOTRACHEAL INTUBATION, BALLOON LEAK INSPECTION WAS PERFORMED ROUTINELY. BALLOON LEAKAGE WAS FOUND, THE ENDOTRACHEAL INTUBATION WAS REPLACED.

  Patient problems: Extubate; No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9562234 ↗
• MalfunctionOct 29, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD AN AIR LEAKAGE FROM THE AIRBAG. THE CUSTOMER INDICATED NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 9253969 ↗
• InjurySep 18, 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

  MAUDE report 9084884 ↗
• InjurySep 2, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AT THE TIME OF PRE-USE CUFF CHECK, PRIOR TO USE IN A PATIENT, THE CUFF COULD NOT BE DEFLATED WELL. IT WAS INDICATED RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8953207 ↗
• MalfunctionAug 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 8891232 ↗
• 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 8891220 ↗
• MalfunctionAug 13, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TUBES HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: No Information

  MAUDE report 8891214 ↗
• InjuryAug 13, 2019Use of Device Problem; Use of Device Problem

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

  Patient problems: Extubate; No Information

  MAUDE report 8891202 ↗
• 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 8858774 ↗
• 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 8858770 ↗
• 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 8858768 ↗
• 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 8858766 ↗
• 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 8858764 ↗
• InjuryAug 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: Extubate

  MAUDE report 8858466 ↗
• InjuryJul 5, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS SLIGHTLY DEFLATED EVEN IT WAS INFLATED WITH THE RECOMMENDED AMOUNT OF AIR INITIALLY. THERE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate; No Information

  MAUDE report 8764298 ↗
• InjuryApr 4, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE. THE REINTUBATION WAS NEEDED.

  Patient problems: Extubate

  MAUDE report 8484253 ↗
• InjuryApr 4, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE. THE REINTUBATION WAS NEEDED.

  Patient problems: Extubate

  MAUDE report 8484208 ↗
• InjuryApr 4, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE. THE REINTUBATION WAS NEEDED.

  Patient problems: Extubate

  MAUDE report 8484184 ↗
• MalfunctionMar 26, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE TUBE CUFF WOULD NOT REMAIN INFLATED AFTER PATIENT INTUBATION. THE CUFF DEFLATED AFTER THE PATIENT INTUBATED AND THIS OCCURRED ON FOUR SEPARATE OCCASIONS. IT WAS INDICATED THAT REINFLATION OF CUFF WAS REQUIRED THROUGHOUT THE PROCEDURE TO MAINTAIN PATENCY OF CIRCUIT.

  Patient problems: No Information

  MAUDE report 8453805 ↗
• InjuryFeb 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, THE DEVICE'S CONNECTOR WAS DETACHED FROM THE TUBE. IT WAS STATED THAT THE CONNECTOR SLIPPED FREE AND POPPED OFF. WHEN THE T-PIECE CONNECTOR WAS REATTACHED, IT WOULD POPPED FREE EASILY, ALTHOUGH IT SAT FLUSH WHEN REPLACED, IT WOULD SLIP OUT. THE CUSTOMER REPORTED PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8364392 ↗
• MalfunctionNov 16, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT THE CUFF WAS BROKEN AND STUCK. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8081293 ↗
• InjurySep 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A LEAK, THE CUSTOMER INDICATED WHEN THEY REMOVED THE TUBE THEY COULD NOT INFLATE THE CUFF ON THE TUBE. THERE WAS A PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Extubate

  MAUDE report 7915727 ↗
• MalfunctionAug 14, 2018Crack; Crack

  ACCORDING TO THE REPORTER, THE TUBING WAS FOUND CRACKED RIGHT AFTER INTUBATION. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781491 ↗