Mallinckrodt 18880Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 30884521032549), received between Apr 6, 2017 and Dec 3, 2021 — classified as 21 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (23 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2021Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE HUB WOULD COME OUT OF THE TUBE SHAFT ITSELF, SO MUCH SO THAT THE PATIENT HAD TO BE REINTUBATED AS IT WOULD NOT STAY CONNECTED.

  Patient problems: Unintended Extubation

  MAUDE report 12923563 ↗
• MalfunctionDec 3, 2021Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE HUB WOULD COME OUT OF THE TUBE SHAFT ITSELF, SO MUCH SO THAT THE PATIENT HAD TO BE REINTUBATED AS IT WOULD NOT STAY CONNECTED.

  Patient problems: Unintended Extubation

  MAUDE report 12923526 ↗
• MalfunctionOct 31, 2021Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE EVENT WAS FOUND EIGHT DAYS AFTER INTUBATION. AN AIR LEAKAGE FROM THE CUFF HAD OCCURRED. IT WAS FOUND THAT THERE WAS A TRACE OF DAMAGE TO THE 15 MM CONNECTOR (CRACKS). THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12725595 ↗
• MalfunctionJan 28, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD A LEAK AFTER PATIENT INTUBATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11245960 ↗
• MalfunctionOct 26, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HOLE IN THE CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10733008 ↗
• MalfunctionJul 2, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING TEST BEFORE USING, THE DEVICE'S CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10227444 ↗
• InjuryMar 30, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS CHECKED FOR LEAKAGE BEFORE USE. THE CUFF LEAK WAS NOTED AFTER INTUBATION. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 9896286 ↗
• InjuryJan 31, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER HALF DAY SINCE THE INTUBATION WAS PERFORMED, A VOICE LEAKED FROM THE PATIENT. THE EXTUBATION WAS PERFORMED AND FOUND A BREAKAGE ON THE CUFF WHEN IT WAS CHECKED IN THE WATER. THEY USED A COMPETITOR'S TUBE AND NO AIR LEAKAGE WAS REPORTED.

  Patient problems: Extubate

  MAUDE report 9654582 ↗
• MalfunctionDec 16, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS AIR LEAKAGE FROM THE CUFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9476439 ↗
• MalfunctionSep 5, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8968120 ↗
• MalfunctionSep 5, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8968108 ↗
• MalfunctionSep 5, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8968104 ↗
• MalfunctionJun 17, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAK. IT WAS STATED THAT THE VENTILATOR ALARMED, INDICATING LOW TIDAL AIR VOLUME. THE AIR BAG PRESSURE MEASURED AT 5 CM H2O WITH NORMAL VITAL SIGNS AND SPUTUM ASPIRATION. THE AIRBAG WAS INFLATED TO 28 CM H2O AND THE VENTILATOR'S TIDAL VOLUME BECOME NORMAL AND THE VENTILATOR DID NOT GIVE AN ALARM. AFTER AN INTERVAL OF 10 MINUTES, THE VENTILATOR GAVE AN ALARM AGAIN. THE TIDAL VOLUME WAS LOW, AND THE AIR BAG PRESSURE WAS MEASURED AT 2 CM H2O.THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704569 ↗
• InjuryJun 13, 2019Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE REPORTER, THREE DAYS AFTER SWITCHING FROM MASK VENTILATION TO TRACHEAL TUBE, THE HOSPITALIZED PATIENT'S CONDITION SUDDENLY CHANGED. AN X-RAY WAS TAKEN AND CYLINDRICAL FOREIGN MATERIAL WAS FOUND. THEY GUESSED THE FOREIGN MATERIAL WAS FOUND IN THE PATIENT'S AIRWAY. THERE WERE 4 SLITS OF 1 CM IN LENGTH AND 5 MM IN DIAMETER.

  Patient problems: No Information

  MAUDE report 8695875 ↗
• InjuryDec 17, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT¿S VOICE WAS HEARD AT REST AND THE SET VENTILATION VOLUME DID NOT ENTER THE VENTILATOR. WHEN CHECKING THE CUFF PRESSURE, IT WAS LESS THAN 10 CM H2O AND AFTER ADJUSTING THE CUFF PRESSURE WITH THE CUFF CHECKER, THE PATIENT¿S VOICE DISAPPEARED AND IT WAS ABLE TO VENTILATE. ABOUT 10 MINUTES AFTER, THE SAME EVENT OCCURRED, THEN THE CUFF PRESSURE WAS ADJUSTED AGAIN AND THE SYMPTOMS DISAPPEARED. THE SAME SITUATION CONTINUED AFTER THAT AND AFTER CHECKING THE INTUBATION POSITION WITH X - RAY, IT WAS CONFIRMED THAT IT DID NOT BECOME SHALLOW, AND THE EXCHANGE OF INTUBATION TUBES WAS CARRIED OUT. AFTER EXCHANGING THE TUBES, IT WAS ABLE TO VENTILATE WITHOUT PROBLEM. THE CUSTOMER REPORTED THAT THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8169153 ↗
• InjuryNov 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD AIR LEAKAGE ON THE CUFF. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 8104793 ↗
• InjuryNov 21, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, AFTER INTUBATION, THE CUFF LEAKED. THERE IS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8096311 ↗
• InjuryNov 21, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE WHEREIN THE CUFF LEAKED. THE CUSTOMER REPORTED THAT PATIENT HAD TO BE REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8094491 ↗
• InjuryOct 31, 2018Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CUFF HAD A HOLE IN IT. THE CUSTOMER REPORTED THAT THE PATIENT WAS RE-INTUBATED.

  Patient problems: Extubate

  MAUDE report 8024715 ↗
• MalfunctionOct 10, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HOLES IN CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7952193 ↗
• InjuryJun 25, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, THERE WAS VOICE LEAKAGE SOON AFTER INTUBATION AND THE CUFF WAS FOUND BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 7634035 ↗
• MalfunctionJun 20, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE CUFF STARTED TO LEAK AFTER 12 DAYS OF USE. PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7620123 ↗
• MalfunctionJun 15, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF STARTED TO LEAK. THE PRODUCT WAS TESTED WITHOUT INCIDENT. THE PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7605347 ↗
• InjuryJun 12, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHILE IN USE ON A PATIENT, THERE WAS AN AIR LEAK FROM THE CUFF WHICH WAS OBSERVED AT THE TIME OF INITIAL CUFF CHECK. IT WAS ALSO REPORTED THAT THE CUFF PRESSURE DID NOT ELEVATE UPON APPLYING AIR TO THE CUFF. CUSTOMER INDICATED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7592614 ↗
• InjuryMay 11, 2018Air Leak; Air Leak

  ACCORDING TO THE REPORTER, THE UNIT'S TUBE WOULD NOT STAY INFLATED AND THEN CUFF LEAK WAS DISCOVERED. PATIENT REQUIRED RE-INTUBATION AND TUBE WAS EXCHANGE TWICE.

  Patient problems: Extubate

  MAUDE report 7507688 ↗