Portex H4021SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315077579), received between May 20, 2021 and Sep 21, 2021 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K790312); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 21, 2021Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE HAD A "SMALL PIN HOLE CRACK" TOWARDS THE MIDDLE OF THE TUBE WHICH WAS DISCOVERED UPON REMOVAL. PATIENT WAS A PREMATURE INFANT WHO HAD COMPLICATIONS FOLLOWING BIRTH LEADING TO INTUBATION WITH A SMITHS MEDICAL ENDOTRACHEAL TUBE AND THE USE OF A CONVENTIONAL VENTILATOR ON (B)(6) 2021. PATIENT CONTINUED TO DO POORLY AND WAS THEN PLACED ON AN OSCILLATOR VENTILATOR, WHERE THE PATIENT DID NOT IMPROVE AND THUS WAS RETURNED TO THE CONVENTIONAL VENTILATOR. DURING THIS TIME, CLINICIANS BELIEVED THAT THE TUBE WAS CAUSING LEAKS IN CERTAIN POSITIONS AND DECIDED TO CHANGE TO A NEW TUBE. IT WAS REPORTED THAT FOLLOWING REMOVAL OF THE TUBE FOR REPLACEMENT, THE SMALL PIN HOLE CRACK? WAS NOTED. THE NEW TUBE WAS PLACED, BUT THE PATIENT DID NOT IMPROVE AND EVENTUALLY CODED AND PASSED AWAY ON (B)(6) 2021. OFFICIAL CAUSE OF DEATH IS UNKNOWN, FURTHER INFORMATION HAS BEEN REQUESTED AND A SUPPLEMENTAL REPORT WILL BE FILED SHOULD FURTHER INFORMATION BE RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12507205 ↗
• MalfunctionMay 20, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858729 ↗
• MalfunctionMay 20, 2021Complete Blockage; Complete Blockage

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE REPORTED THE SMALL WHITE SCREW ON CAP AT THE SIDE OF THE ET TUBE WAS NOT REMOVED BY A STAFF AND THE FIRST INSTANCE INVOLVED A WHOLE NEW VENTILATION CIRCUIT BEING USED, STAFF COULD NOT IDENTIFY WHY THE CIRCUIT WAS NOT WORKING. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790312. One submission often covers many models, so check the product and lot details in each record.

• Z-1289-2025 · Feb 13, 2025 · Open, Classified
  Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025
• Z-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-2536-2014 · Jul 7, 2014 · Terminated
  4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-1641-2014 · Apr 10, 2014 · Terminated
  Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space con