Portex 100/127/025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315019807), received between Mar 2, 2023 and Jul 15, 2026 — classified as 2 injuries, 3 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

5 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 18, 2026.

Recalls naming this device

1. Feb 13, 2025Class IOpen, Classified

   Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

   Z-1289-2025 · Root cause: Process change control · Recall details · FDA record ↗

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.

• MalfunctionJul 15, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826019 ↗
• InjuryJun 30, 2026Material Too Soft/Flexible

  The following incident details are based on information received from the distributor through their direct contact with the facility customer: Additional information from the distributor was received on (b)(6) 2026 stating that the patient expired. The distributer stated that after the patient was transferred to Montreal Children¿s Hospital, the patient remained ¿critically ill and unstable¿ throughout the hospitalization. The distributor also indicated the clinical course was complicated by an intraventricular hemorrhage. The patient expired on (b)(6) 2026. According to the distributor, 8 devices were used to intubate the patient, and 7 are alleged to be Portex Endotracheal tubes. Of those 7, one lot number is known and the others are unknown. At this time, it is not known if all 7 devices were ICU Medical devices. This is report 1 of 2 referencing the same patient due to the item and lot numbers that were used during the event not being able to be verified at this time. The distributor stated that due to multiple risks inherent to extreme prematurity and complex postnatal clinical care, a definitive causal relationship between the reported events and the fatal outcome cannot be e

  Patient problems: Decreased Respiratory Rate; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25669284 ↗
• MalfunctionJan 28, 2026Material Integrity Problem

  IT WAS REPORTED THAT ON THE SECOND ATTEMPT, THEY USED A STYLET, AND THE ENDOTRACHEAL TUBE (ETT) SCRUNCHED LIKE AN ACCORDION WHEN THE STYLET WAS REMOVED. THE FAULT WAS FOUND WHILE THE DEVICE WAS IN USE WITH A PATIENT. THE PATIENT HARM WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199467 ↗
• MalfunctionNov 26, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT OVER THE PAST YEAR, THEY HAVE OBSERVED A NOTICEABLE DECLINE IN THE RIGIDITY OF THE 2.5 MM ENDOTRACHEAL TUBES FOLLOWING THE MARCH 2025 RECALL. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM. AN ADDITIONAL INFORMATION ABOUT THE ISSUE WAS THE TUBE IS LESS RIGID THAN OTHER LOTS. MAKING VERY DIFFICULT TO INTUBATE A MICRO PREEMIE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658219 ↗
• InjuryMar 2, 2023Break; Break

  IT WAS REPORTED THAT THE PLASTIC COATING OF STYLET WAS DETACHED FROM STYLET WHEN STYLET REMOVED FROM THE ENDOTRACHEAL TUBE (ETT) AFTER INTUBATION. A 10CM (CENTIMETER) PIECE OF PLASTIC COATING REMAINED IN THE ENDOTRACHEAL TUBE (ETT) WHICH WAS IN THE PATIENTS ESOPHAGUS. THE PATIENT WAS ELECTIVELY EXTUBATED DUE TO THE PLASTIC PIECE IN ORIGINAL ENDOTRACHEAL TUBE (ETT) AND REINTUBATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468395 ↗

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-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn 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-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder 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