Portex 100/126/030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315056765), received between Mar 7, 2023 and Aug 12, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SIZE LENGTH OF THE ENDOTRACHEAL TUBE WAS ONLY 4 ¿ INCHES LONG. IT WAS CUT ON 12 CENTIMETERS AT THE LIP, WHICH WAS NORMALLY WENT TO 6 CENTIMETERS PLUS. THERE WAS ALSO NO MURPHY EYE AT THE END OF THE TRACH TUBE. THE EVENT OCCURRED DIRECTLY ON USE WITH THE PATIENT AT L&D OR A, AS THERE WAS NO OTHER OPTION AVAILABLE TO USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786024 ↗
• MalfunctionOct 21, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE BALLARD 8 FR. INLINE SUCTION CATHETER COULD NOT BE ADVANCED DOWN THE TUBES. ON TWO INSTANCES THEY HAVE NEEDED TO RE-INTUBATE BABIES WITH AN ALTERNATE TUBE TO ENSURE PROPER BRONCHIAL HYGIENE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495271 ↗
• InjuryNov 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE TAKING THE BLUE ADAPTER OFF THE ETT, IT BROKE LEAVING A PIECE LODGED IN THE TUBE. THE PATIENT HAD TO BE EXTUBATED AND REINTUBATED. THERE WAS PATIENT INVOLVED BUT NO INJURY WAS REPORTED. THEY HAD NO FURTHER ISSUES BUT WOULD NOT CONSIDER IT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076849 ↗
• InjuryNov 6, 2023Fracture; Blocked Connection; Fracture; Blocked Connection

  IT WAS REPORTED THAT WHILE TAKING THE BLUE ADAPTER OFF THE ETT, IT BROKE LEAVING A PIECE LODGED IN THE TUBE. THE PATIENT HAD TO BE EXTUBATED AND REINTUBATED. THERE WAS PATIENT INVOLVED BUT NO INJURY WAS REPORTED. IT WAS REPORTED THAT THE LOT NUMBERS ARE UNKNOWN. THE CUSTOMER REPORTED THAT "THEY HAD NO FURTHER ISSUES BUT WOULD NOT CONSIDER IT RESOLVED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074978 ↗
• InjuryOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE TAKING THE BLUE ADAPTER OFF THE ETT, IT BROKE LEAVING A PIECE LODGED IN THE TUBE. THE PATIENT HAD TO BE EXTUBATED AND REINTUBATED. THERE WAS PATIENT INVOLVED BUT NO INJURY WAS REPORTED. THEY HAD NO FURTHER ISSUES BUT WOULD NOT CONSIDER IT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006817 ↗
• MalfunctionMar 7, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT A BABY WAS INTUBATED WITH A 3.0 ENDOTRACHEAL TUBE (ETT). THE CUSTOMER WENT TO GO SUCTION THE BABY AND NOTICED IT WAS UNABLE TO PASS THE 8FR CATHETER PAST THE TAPES. IT IS BELIEVED THE TAPES WERE TIGHT SO THE CUSTOMER HAD THE TAPES READJUSTED. AFTER READJUSTING THE TAPES THE CUSTOMER WAS STILL UNABLE TO PASS THE 8 FR CATHETER. TRIED ANOTHER CATHETER BUT STILL COULDN'T GET IT DOWN. ENDED UP HAVING TO PUT A 6FR SUCTION CATHETER IN. THE ENDOTRACHEAL TUBE (ETT) WAS REMOVED AND NO ISSUES PASSING AN 8FR CATHETER. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499718 ↗

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-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm 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-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm 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