Mallinckrodt 18875Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 30884521032532), received between Apr 6, 2017 and May 15, 2025 — classified as 20 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (12 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.

• MalfunctionMay 15, 2025Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE TUBE WAS PLACED, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE COULD NOT BE FIXED IN THE AIRWAY. AFTER IT WAS PULLED OUT FOR INSPECTION, IT WAS FOUND THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS LEAKING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22030819 ↗
• MalfunctionSep 20, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFFS OF THE THREE ENDOTRACHEAL TUBES WERE "RUPTURED". THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273016 ↗
• InjuryApr 28, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, AFTER A WEEK OF INTUBATION, SEVERE SWELLING AND BLISTERING OF THE TRACHEA WALLS WHERE CUFF WAS INFLATED WAS FOUND. IT WAS REPORTED THAT THE PATIENT HAD ALLERGY TO SULFA. THE PATIENT HAD TO BE TRACHED BECAUSE OF THE PATIENT'S REACTION TO THE ETT (ENDOTRACHEAL TUBE).

  Patient problems: Localized Skin Lesion; Unintended Extubation

  MAUDE report 11739959 ↗
• MalfunctionApr 27, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED TRACHEAL INTUBATION OPERATION ON (B)(6) 2021. THE CUFF WAS FOUND TO BE LEAKING AIR AFTER THE OPERATION, SO THE TRACHEAL INTUBATION WAS REPLACED. AFTER THE REPLACEMENT, THE USE WAS NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11733788 ↗
• MalfunctionJan 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE INTUBATION, THE DEVICE'S CUFF MADE A LOUD NOISE AND BROKE ON THE TRACHEA OF THE PATIENT. IT WAS ALSO STATED THAT THE CUFF WAS PRE-TESTED AND FOUND NO PROBLEM. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11185084 ↗
• InjuryMay 11, 2020Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST USE, THE DEVICE HAD QUALITY ISSUES. THE PATIENT WAS DEAD.

  Patient problems: Death

  MAUDE report 10043709 ↗
• InjuryJan 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF WAS TORN. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 9622329 ↗
• InjuryNov 7, 2019Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN THEY TOOK THE TUBE OUT DUE TO LEAKING CUFF, THEY NOTICED A TEAR IN THE CUFF.

  Patient problems: Extubate

  MAUDE report 9293404 ↗
• MalfunctionSep 18, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085093 ↗
• MalfunctionSep 18, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF HAD AIR LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9083836 ↗
• InjurySep 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS POSSIBLY BROKE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8978199 ↗
• InjuryAug 27, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS AN AIR LEAKAGE FROM THE ENDOTRACHEAL INTUBATION BALLOON. AFTER EXTUBATION, THE PATIENT'S BREATH ING, OXYGENATION AND ELECTROLYTES WERE CLOSELY MONITORED AND THE ENDOTRACHEAL INTUBATION WAS REINSERTED.

  Patient problems: Extubate

  MAUDE report 8937178 ↗
• MalfunctionAug 2, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS TRANSFERRED TO THE ICU FOR TRACHEAL INTUBATION VENTILATOR ASSISTED DUE TO TYPE II RESPIRATORY FAILURE, WHILE STRENGTHENING ANTI-INFECTION TREATMENT. IN THE VENTILATION PROCESS, THE VENTILATOR INTERMITTENTLY INDICATED THAT THERE WAS A LEAK, AND AFTER THE BALLOON WAS INFLATED IT IMPROVED. TRACHEAL INTUBATION WAS REMOVED AND THE BALLOON WAS FOUND TO BE SEVERELY LEAKING. IT WAS REPORTED THAT THE TREATMENT WAS EXTENDED.

  Patient problems: No Information

  MAUDE report 8857231 ↗
• InjuryJul 10, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS ATTACHED TO THE PILOT BALLOON BUT AFTER CONNECTING FOR SEVERAL DAYS, IT BECAME DISCONNECTED. IT WAS REPORTED THAT EVEN IT WAS ATTACHED, IT FELT LIKE BEING BOUNCE BACK DUE TO A PRESSURE AND CAME OFF IMMEDIATELY. THEY GAVE UP THE MANAGEMENT WITH THE AUTOMATIC CUFF PRESSURE CONTROLLER AND SWITCHED TO MANUAL BUT THE CONTROLLER STILL CAME OFF. ALTHOUGH IT WAS REPLACED WITH THE CUFF PRESSURE GAUGE, THE CONTROLLER STILL CAME OFF THE PILOT BALLOON OF THE TUBE. RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8776611 ↗
• InjuryApr 5, 2019Disconnection; Connection Problem; Disconnection; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT ADAPTER WAS REPEATEDLY DISCONNECTED WHILE ON PATIENT. THE CUSTOMER STATED MULTIPLE INTERVENTIONS ATTEMPTED INCLUDING TAPING THE CONNECTION HOWEVER THE CONNECTION REMAIN LOOSE. THE CUSTOMER STATED INTUBATION WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 8488478 ↗
• MalfunctionMar 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, THE WHITE PLASTIC ADAPTER THAT CONNECTS DIRECTLY INTO THE TRACHEAL TUBE REPEATEDLY DISCONNECTED WHILE ON A PATIENT. MULTIPLE INTERVENTIONS WERE ATTEMPTED INCLUDING TAPING THE CONNECTION, HOWEVER THE CONNECTION REMAINED LOOSE AND RESULTED IN NUMEROUS DISCONNECTIONS FROM THE VENTILATOR.

  Patient problems: No Information

  MAUDE report 8465598 ↗
• MalfunctionMar 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, THE WHITE PLASTIC ADAPTER THAT CONNECTS DIRECTLY INTO THE TRACHEAL TUBE REPEATEDLY DISCONNECTED WHILE ON A PATIENT. MULTIPLE INTERVENTIONS WERE ATTEMPTED INCLUDING TAPING THE CONNECTION, HOWEVER THE CONNECTION REMAINED LOOSE AND RESULTED IN NUMEROUS DISCONNECTIONS FROM THE VENTILATOR.

  Patient problems: No Information

  MAUDE report 8465567 ↗
• InjuryJan 31, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS RUPTURED ON THE THIRD DAY OF BEING USED AND WAS CONFIRMED HAVING A LEAKAGE BUT COULD NOT FIND THE VISIBLE HOLE. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 8293782 ↗
• InjuryNov 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHEN INJECTING THE AIR INTO THE CUFF WITH THE CUFF CHECKER AFTER THE TUBE WAS INTUBATED ORALLY, THE CUFF PRESSURE DID NOT INCREASE AND THERE WAS A DOUBT OF AIR LEAKAGE FROM THE CUFF. CUSTOMER INDICATED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED/PERFORMED.

  Patient problems: Extubate

  MAUDE report 8104843 ↗
• InjuryNov 16, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THEY WERE UNABLE TO INTUBATE DUE TO AN AIR LEAK. AFTER REMOVING THE TUBE, THEY FILLED IT WITH NORMAL SALINE AND OBSERVED A HOLE IN THE BALLOON. THE PATIENT NEEDED TO BE INTUBATED THREE TIMES AND THAT MEDICINE WAS ISSUED TO PREVENT CODING.

  Patient problems: Extubate

  MAUDE report 8081270 ↗
• InjuryJun 28, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS TESTED WITHOUT INCIDENT, HOWEVER THE CUFF STARTED TO LEAK AFTER FEW HOURS. THE CUSTOMER INDICATED THAT THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 7645522 ↗
• MalfunctionJun 27, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE TUBE KEPT SEPARATING FROM THE HUB, RESULTING IN NEEDING TO BE REATTACHED QUITE A FEW TIMES. THE CUSTOMER REPORTED THAT TUBE WAS FOUND DISLODGED AND RECONNECTED. IT WAS INDICATED THAT THE TUBE WAS REMOVED AND A TRACHEOSTOMY TUBE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642141 ↗
• MalfunctionJun 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF STARTED TO LEAK AFTER FEW HOURS. IT WAS REPORTED THAT IT WAS TESTED WITHOUT INCIDENT. IT WAS REPORTED THAT RE-CANNULATION OF A REPLACEMENT TUBE WAS UNKNOWN. THE CUSTOMER REPORTED THAT PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7613422 ↗
• MalfunctionJun 15, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE TUBE KEPT SEPARATING FROM THE HUB, RESULTING IN IT NEEDING TO BE REATTACHED QUITE A FEW TIMES. THE CUSTOMER REPORTED THAT TUBE WAS FOUND DISLODGED AND RECONNECTED. PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7605464 ↗
• MalfunctionJun 15, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE TUBE KEPT SEPARATING FROM THE HUB, RESULTING IN IT NEEDING TO BE REATTACHED QUITE A FEW TIMES. THE CUSTOMER REPORTED THAT TUBE WAS FOUND DISLODGED AND RECONNECTED. PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7605449 ↗