Portex 100/111/025Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15019315018848), received between Feb 1, 2022 and Sep 9, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE STYLET GOT TWISTED INSIDE THE TUBE AND WOULD NOT ALLOW THE STYLET TO BE PULLED OUT. REPORTER STATED THAT THIS HAPPENED TWICE: ONCE THE STYLET JUST GOT STUCK, THE SECOND ONE TWISTED INSIDE OF THE STYLET. REPORTER STATED THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE EVENT OCCURRED WHEN ATTEMPTING INTUBATION ON AN INFANT IN THE NURSERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009128 ↗
• MalfunctionMar 19, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ¿THE TUBES ARE SO LOOSE THAT THEY CANNOT BE INTUBATED WITH¿. THE PRODUCTS WERE FAULTY WHEN INTUBATING THE PATIENT. THE PATIENT WAS NOT INJURED BUT RELATIVES BECAME CONCERNED WHEN INTUBATION FAILED AND WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937456 ↗
• MalfunctionMar 19, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ¿THE TUBES ARE SO LOOSE THAT THEY CANNOT BE INTUBATED WITH¿. THE PRODUCTS WERE FAULTY WHEN INTUBATING THE PATIENT. THE PATIENT WAS NOT INJURED BUT RELATIVES BECAME CONCERNED WHEN INTUBATION FAILED AND WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937390 ↗
• InjurySep 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CHILD'S POSITIONING HAD TO BE CHANGED SEVERAL TIMES IN ORDER TO PREVENT THE VENTILATOR FROM "SOUNDING OCCLUDED AND THE CHILD FROM UNDER-VENTILATING". THE CHILD SHOULD BE POSITIONED WITH HEAD HYPEREXTENSION TO BE PROPERLY VENTILATED. PATIENT SUFFERED RESPIRATORY INSTABILITY. THE DEVICE WAS DISCARDED AFTER EXTUBATION.

  Patient problems: Respiratory Insufficiency

  MAUDE report 17777814 ↗
• MalfunctionSep 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT TO PREVENT THE VENTILATOR FROM SOUNDING, THE CHILD IS OCCLUDED FROM UNDER-VENTILATION, AND HE SHOULD BE POSITIONED WITH THE HEAD HYPEREXTENDED TO ENSURE CORRECT VENTILATION. THERE IS A NEED FOR REPOSITIONING THE CHILD SEVERAL TIMES AND THESE ACTIONS DETERMINE SIGNIFICANT RESPIRATORY DETERIORATION. THE ACTUAL DEVICE IS IN USE WITH THE PATIENT AND WILL BE PROVIDED FOR INVESTIGATION AFTER THE THERAPY IS DONE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 17777414 ↗
• InjuryAug 29, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CHILD IS FITTED WITH A 2.5 INTUBATION TUBE. WHENEVER IT IS INSTALLED VENTRAL ON THE LEFT SIDE, THE PROBE DOES NOT VENTILATE EFFICIENTLY. THE VENTILATOR RINGS IN OCCLUSION AND THE VENTILATION CURVE SHOWS UNDER VENTILATION. AS SOON AS WE REPOSITION THE CHILD ON THE BACK THE OCCLUSION RISES. VERIFICATION THAT THERE ARE NO OBSTACLES INSIDE THE PROBE THAT DO NOT PRESENT. IMPOSSIBLE TO INSTALL THE CHILD IN THIS WAY WHICH IS NOT IN MATCH WITH HER NEEDS. WE OBSERVED A SLOWING OF THE CHILD'S HEART RATE AS WELL AS ONLY DESATURATION AND HYPERCAPNIA, UNTIL THE REMOBILIZATION OF THE CHILD IN A POSITION WHERE THE INTUBATION TUBE ALLOWS VENTILATION EFFECTIVELY. IN ITSELF ONLY RIGHT SUPPORT IN VENTRAL AND DORSAL. FEMALE, 5 DAYS OLD, WEIGHT 0.7KG.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 17647574 ↗
• InjuryAug 28, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTY DURING USE. IF THEY PLACE THE CHILD IN THE LEFT PRONE POSITION, THE VENTILATOR SOUNDS IN VENTILATION OCCLUSION. THE VENTILATION CURVE SHOWS THAT THE CHILD IS UNDER-VENTILATED, DESPITE AN ADAPTED POSITION (PROBE NOT ANGLED, CHILD'S HEAD IN THE RIGHT AXIS). THIS REQUIRES THE HEAD TO BE POSITIONED DURING CARE (DORSAL DECUBITUS) TO ENSURE APPROXIMATE VENTILATION. POSITIONING THE CHILD IN THE RIGHT PRONE POSITION POSES NO PROBLEM. VENTILATION IS GUARANTEED AND EFFECTIVE. THE CUSTOMER HAS SAID THAT THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE PROBE IS STILL IN PLACE ON THE PATIENT. DESATURATION OF THE CHILD WAS OBSERVED, AS WELL AS A SLOWING OF THE HEART RATE AND AN INCREASE IN TRANSCUTANEOUS CAPNIA. THIS RESULTED IN SIGNIFICANT DESTABILIZATION FOR A 600-GRAM CHILD.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 17637443 ↗
• MalfunctionOct 11, 2022Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IT WAS REPORTED THAT THE TRACH TUBE HAD A CRACK IN THE BLUE HUB, AND A GAPING HOLE WAS OBSERVED. THE PRODUCT HAD NO DEFECTS WHEN TAKEN OUT OF THE PACKET. THE BLUE PLASTIC HUB WAS LEFT IN THE ENDO TRACHEAL TUBE AND COULD NOT BE REMOVED, IT WAS COMPLETELY STUCK. THIS CAUSED THE USER TO HAVE TO REINTUBATE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER RESPONSE EMAIL 20-SEP-2022 STATING THE ISSUE WAS DISCOVERED IMMEDIATELY AFTER INTUBATION OF THE PATIENT, UPON HAVING NO PEDICAP CHANGE DESPITE THE TUBE CLEARLY BEING THRU THE CORDS, LOT NUMBER IS NOT KNOWN. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT AFTER THE COMPLETION OF THE RE-INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577446 ↗
• MalfunctionSep 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE CONNECTOR WAS SEPARATED FROM THE TUBE BEFORE USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353884 ↗
• InjuryAug 25, 2022Material Fragmentation; Difficult to Advance; Material Fragmentation; Difficult to Advance

  IT WAS REPORTED THAT DURING REINTUBATION, CUSTOMER WAS UNABLE TO PASS SUCTION CATHETER DOWN THE TRACH TUBE. THE BLUE CONNECTOR SEEMED TO BE AT AN ODD ANGLE AS IT WAS INSERTED INTO THE TUBE ITSELF. ASSESSMENT NOTED THE BLUE [CONNECTOR] OF TRACH TUBE (THE PART THAT FITS INTO THE TUBE) WAS CHIPPED AND A SMALL SEGMENT HAD BROKEN OFF. UNSURE IF BROKEN PRIOR TO USE OR WHILST IN-SITU AS IT WAS A DIFFICULT AND TIMELY INTUBATION. MEDICS WERE INFORMED AND BABY WAS ASSESSED. THE TRACH TUBE WAS REMOVED FROM USE AND REPLACED. AN X-RAY OF THE CHEST WAS PERFORMED TO RULE OUT A FOREIGN OBJECT IN LUNG FIELD. NO EVIDENCE OF BLOCKAGE FOUND SO IT WAS DECIDED TO CONTINUED WITH CURRENT PLAN OF CARE. NO INTERFERENCE WITH VENTILATION NOTED. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294737 ↗
• MalfunctionFeb 7, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS BROKEN PLASTIC UPON ARRIVAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470509 ↗
• MalfunctionFeb 1, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS BROKEN PLASTIC UPON ARRIVAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419115 ↗
• MalfunctionFeb 1, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS BROKEN PLASTIC UPON ARRIVAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419032 ↗

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-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