Portex 100/189/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 15019315059544), received between May 25, 2016 and Sep 21, 2026 — classified as 34 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Complete Blockage

  Patient problems: Respiratory Insufficiency

  MAUDE report 50843035 ↗
• MalfunctionJul 6, 2026Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT, FOLLOWING INTUBATION, THE PHYSICIAN INJECTED WATER INTO THE CUFF USING A SYRINGE; HOWEVER, THE CUFF WAS FOUND TO BE LEAKING. AS A RESULT, THE PHYSICIAN REMOVED THE TUBE AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719675 ↗
• InjuryDec 29, 2025Material Puncture/Hole; Gas/Air Leak; Material Split, Cut or Torn; Material Puncture/Hole; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT¿S TUBE WAS REPLACED IN RESPONSE TO A VENTILATOR LEAK ALARM. DURING THE REPLACEMENT, RE-INTUBATION WAS PROLONGED, AND THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION.

  Patient problems: Cardiac Arrest

  MAUDE report 23906258 ↗
• InjuryJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLON OF THE TRACHEAL TUBE SEEMED TO BE LEAKING. THIS CAUSED THE PATIENT TO BE CONTINUOUSLY INTUBATED, SEDATED AND PUT ON ANALGESIC MEDICATIONS (REMIFENTANIL AND CIPROFOL) AND APPEARED TO BE INTERMITTENTLY IRRITABLE AND COULD NOT COMMUNICATE EFFECTIVELY. THE CARE TEAM EVENTUALLY CHANGED THE ENDOTRACHEAL TUBE.

  Patient problems: Irritability

  MAUDE report 22575330 ↗
• MalfunctionJul 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AN INTUBATED PATIENT WAS TREATED WITH A VENTILATOR, WHEN AN ENDOTRACHEAL TUBE WITH SUBGLOTTIC CHANNEL NO. 8.0 WAS INSERTED. THE VENTILATOR HAD A SLIGHT DIFFERENCE BETWEEN INSPIRATORY AND EXPIRATORY TIDAL VOLUME, BUT NO DIFFICULTY IN VENTILATING THE PATIENT. IN CONNECTION WITH TRANSFERRING THE PATIENT TO A DIFFERENT HOSPITAL, A SMALL WHEEZING SOUND IS HEARD, AND A DECISION IS MADE TO CHANGE THE TUBE. UPON INSPECTION, IT TURNS OUT THAT THERE IS A HOLE IN THE TRACHEAL TUBE AROUND THE WELDING. THE TRACHEAL TUBE IS SAVED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566845 ↗
• MalfunctionMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF EXHIBITED A LEAKAGE. THE CUFF INJECTION WAS DAMAGED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115989 ↗
• InjuryMay 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON OF THE TRACHEAL TUBE SEEMED TO BE LEAKING. THIS CAUSED THE PATIENT TO BE CONTINUOUSLY INTUBATED, SEDATED AND PUT ON ANALGESIC MEDICATIONS (REMIFENTANIL AND CIPROFOL) AND APPEARED TO BE INTERMITTENTLY IRRITABLE AND COULD NOT COMMUNICATE EFFECTIVELY. THE CARE TEAM EVENTUALLY CHANGED THE ENDOTRACHEAL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081930 ↗
• MalfunctionApr 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED IN THE REPORT THAT THE INTENSIVE CARE MEDICINE DOCTOR DISCOVERED A LEAK IN THE INTUBATION TUBE WHILE USING IT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778254 ↗
• MalfunctionFeb 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOUR PATIENTS WITH SIZE 8.0 SACHET TUBES HAVE REQUIRED ENDOTRACHEAL TUBE CHANGES FOR PERSISTENTLY DEFLATING CUFFS IN THE ICU OVER THE LAST 5 DAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294116 ↗
• MalfunctionFeb 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOUR PATIENTS WITH SIZE 8.0 SACHET TUBES HAVE REQUIRED ENDOTRACHEAL TUBE CHANGES FOR PERSISTENTLY DEFLATING CUFFS IN THE ICU OVER THE LAST 5 DAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293859 ↗
• MalfunctionFeb 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOUR PATIENTS WITH SIZE 8.0 SACETT TUBES HAVE REQUIRED ENDOTRACHEAL TUBE CHANGES FOR PERSISTENTLY DEFLATING CUFFS IN THE ICU OVER THE LAST 5 DAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293745 ↗
• MalfunctionFeb 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT FOUR PATIENTS WITH SIZE 8.0 SACHET TUBES HAVE REQUIRED ENDOTRACHEAL TUBE CHANGES FOR PERSISTENTLY DEFLATING CUFFS IN THE ICU OVER THE LAST 5 DAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293727 ↗
• MalfunctionDec 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE BRONCHOSCOPE FIBER WAS INSERTED INTO THE TUBE, THERE WAS A PROTRUSION INSIDE AND IT BECAME STUCK AND WOULD NOT PASS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832513 ↗
• MalfunctionNov 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ADAPTER WAS EASILY DETACHED FROM THE ENDOTRACHEAL TUBE EVEN THOUGH REPORTER TIGHTENED THE ENDOTRACHEAL TUBE ADAPTER. THE PATIENT WAS LEFT WITHOUT RESPIRATORY SUPPORT. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE/HARM EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727187 ↗
• MalfunctionAug 8, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT WHEN A HEMOSTATIC BALLOON CATHETER WAS INSERTED INTO THE SUCTION LINE ABOVE THE CUFF, IT WAS CONFIRMED THAT THE CATHETER HAD POOR SUCTION AT THE TOP OF THE CUFF. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939436 ↗
• MalfunctionMay 20, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AIR LEAKAGE FROM CUFF." THIS OCCURRED DURING PRIMING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350981 ↗
• MalfunctionJul 11, 2023Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER NOTICED THAT THE INTUBATION TUBE WAS "SHEDDING" SOME SORT OF PLASTIC FILM. THIS APPEARED TO BE "DISINTEGRATING" WHICH PROMPTED THE PATIENT TO BE RE-INTUBATED. THE TUBE HAD BEEN IN PLACE FOR TWENTY TWO (22) DAYS. A SMALL PIECE OF PLASTIC CAME OFF AND STUCK TO THE END OF THE FIBERSCOPE. "SMALL PIECES OF PLASTIC CAN BE PLACED DISTALLY AT THE TIME OF TRACHEAL ASPIRATIONS BY THE CARERS, ESPECIALLY WHEN THEY ADMINISTER SALINE AT THE SAME TIME TO THIN THE SECRETIONS". NO ADVERSE EFFECTS REPORTED AND THE OUTCOME WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 17303239 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE IS USE WITH A PATIENT THE CUSTOMER WAS CHECKING THE CUFF PRESSURE USING THE CUFF PRESSURE GAUGE WITH EXTENSION TUBING. WHEN THE EXTENSION TUBING WAS REMOVED, THE RED CAP BECAME DETACHED. NO PATIENT INJURY REPORTED. IT HAS BEEN REPORTED THAT NO ADDITIONAL INFORMATION WILL BE AVAILABLE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817019 ↗
• MalfunctionApr 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT HAD BEEN INTUBATED FOR 48 HOURS WITH STABLE RESPIRATORY. A BRONCHOSCOPY WAS DONE TO CHECK FOR POSSIBLE ASPERGILLOSIS AND IT WAS SEEN THAT THE TUBE SEEMED TO BE DISINTEGRATING FROM THE INNER LAYER. THE MIDDLE LOWER PART OF THE TUBE SEEMED TO BE SHEDDING. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727468 ↗
• MalfunctionMar 29, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS KINKED. IT WAS NOT POSSIBLE TO GET AIR INTO THE PATIENT DURING INTUBATION. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16639444 ↗
• MalfunctionMar 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE IN USE, THE INFLATION LINE WAS ADHERED TO THE TUBE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589232 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE PRODUCT, A CUFF LEAK WAS OBSERVED. NO PATIENT INJURY, NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585374 ↗
• InjuryFeb 24, 2023Obstruction of Flow; Deformation Due to Compressive Stress; Obstruction of Flow; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE ETT (ENDOTRACHEAL TUBE) TUBE WAS KINKED AND APPEARED TO HAVE WEAKNESS AT APPROACH 18CM/SUBGLOTTIC TUBING. UNABLE TO PASS SUCTION CATHETER, ABLE TO PASS BRONCHOSCOPY WITH DIFFICULTY, UNABLE TO MANUALLY UNKINK. IT WAS ALSO REPORTED THAT THE PATIENT REQUIRED BRONCHOSCOPY, ETT (ENDOTRACHEAL TUB) CHANGE WITH SUDATION AND SUBSEQUENTLY DE- RECRUITED AND REQUIRED HIGHER FI02 (FRACTION OF INSPIRED OXYGEN) OVERNIGHT. CUSTOMER REPORTED THAT THEY DID NOT HAVE THE PACKAGE FOR THE FAULTY DEVICE. THE LOT NUMBER PROVIDED IS FROM THE ITEM IN THE SAME STOCK LOCATION. NOT THE IDEAL ONE.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 16439820 ↗
• InjuryJan 9, 2023Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT CUFF LEAKED AND DEFLATED UPON INTUBATION. CUSTOMER REQUESTED PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED ON 22-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: CUSTOMER CONFIRMED THE QUANTITY AFFECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121381 ↗
• InjuryJan 9, 2023Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT CUFF LEAKED AND DEFLATED UPON INTUBATION. CUSTOMER REQUESTED PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED ON 22-DEC-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: CUSTOMER CONFIRMED THE QUANTITY AFFECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121297 ↗