Portex 100/166/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315054075), received between May 15, 2017 and Dec 28, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS INSERTING THE PRODUCT IN THE PATIENT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. THIS EVENT WAS SEEN IN THE TWO (2) PRODUCTS CONSECUTIVELY, AND THE THIRD (3RD) PRODUCT WAS INTUBATED WITH NO PROBLEM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061109 ↗
• InjuryDec 20, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS INSERTING THE PRODUCT IN THE PATIENT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. THIS EVENT WAS SEEN IN THE TWO (2) PRODUCTS CONSECUTIVELY, AND THE THIRD (3RD) PRODUCT WAS INTUBATED WITH NO PROBLEM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017324 ↗
• MalfunctionFeb 3, 2022Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  IT WAS REPORTED THAT DURING PRE-USE CHECK, THE CUSTOMER FOUND A CRACK IN THE INFLATION LINE. LEAKAGE OF AIR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446778 ↗
• MalfunctionJun 18, 2018Air Leak; Leak/Splash; Material Split, Cut or Torn; Air Leak; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER INSERTED THE PRODUCT INTO THE PATIENT AT NIGHT. THE NEXT MORNING, THEY NOTICED AIR LEAKAGE FROM IT. UPON CHECKING IT, THEY FOUND A PINHOLE IN IT AND STOPPED USING IT. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611363 ↗
• MalfunctionMay 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SLIP JOINT AND THE TUBE OF A PORTEX® SILICONISED PVC, ORAL/NASAL SOFT SEAL® CUFF TRACHEAL TUBE CAME OFF DURING USE OF THE PRODUCT. NO INJURY WAS REPORTED, AND THE OUTCOME OF THE EVENT WAS REPORTED TO BE FULL RESOLUTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567700 ↗

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-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-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm 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