Portex 100/166/050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315054044), received between Apr 25, 2018 and Apr 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2020Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED ON APRIL 16TH,2020. THE EVENT OCCURRED DURING PATIENT RECEIVING SUCTIONING WHILE INTUBATED. THE SUCTION CATHETER WOULD NOT PASS, EVEN AFTER POSITIONING PATIENT AND WASHING WITH NORMAL SALINE TO LOOSEN MUCOUS PLUG. DO TO FAILURE OF SUCTIONING, THE PATIENT ENDURED INSERTING ANOTHER TRACHEAL TUBE WITH SEDATION OF PARALYTIC. VENTILATOR PRESSURES WERE ADJUSTED HIGHER AND INCREASE OXYGEN LEVEL. THE FILE IS NOW CONSIDERED SERIOUS INJURY REPORTABLE, AS COMPROMISE OF AIRWAY CONTROL WAS JEOPARDIZED. WHEN THE OLD TRACHEAL TUBE WAS REMOVED CAUSE OF EVENT WAS RELATED TO KINKED TUBE. PATIENT WAS SUCCESSFULLY REINTUBATED BUT AT HIGH RISK FOR LOSS OF AIRWAY MANAGEMENT.

  Patient problems: Airway Obstruction; Hypoxia

  MAUDE report 9981784 ↗
• MalfunctionApr 21, 2020Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 16TH,2020. THE EVENT OCCURRED DURING PATIENT RECEIVING SUCTIONING WHILE INTUBATED. THE SUCTION CATHETER WOULD NOT PASS, EVEN AFTER POSITIONING PATIENT AND WASHING WITH NORMAL SALINE TO LOOSEN MUCOUS PLUG. DO TO FAILURE OF SUCTIONING, THE PATIENT ENDURED INSERTING ANOTHER TRACHEAL TUBE WITH SEDATION OF PARALYTIC. VENTILATOR PRESSURES WERE ADJUSTED HIGHER AND INCREASE OXYGEN LEVEL. THE FILE IS NOW CONSIDERED SERIOUS INJURY REPORTABLE, AS COMPROMISE OF AIRWAY CONTROL WAS JEOPARDIZED. WHEN THE OLD TRACHEAL TUBE WAS REMOVED CAUSE OF EVENT WAS RELATED TO KINKED TUBE. PATIENT WAS SUCCESSFULLY REINTUBATED BUT AT HIGH RISK FOR LOSS OF AIRWAY MANAGEMENT.

  Patient problems: Airway Obstruction; Hypoxia

  MAUDE report 9981748 ↗
• MalfunctionApr 25, 2018Air Leak; Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT RESISTANCE WAS MET WHEN ATTEMPTING TO INFLATE THE CUFF TO A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7457853 ↗

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-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder 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-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