Portex 100/141/030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15019315019036), received between Sep 14, 2020 and Jun 21, 2024 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (5 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.

• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE AND THE CONNECTION PORT WERE BROKEN. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588525 ↗
• InjuryMay 8, 2024Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE (B)(6) HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. FOR THIS REPORTED MALFUNCTION AT THE TIME OF THE EVENT THE PATIENT WAS 44 DAYS OLD; 29+1WEEKS CORRECTED. WEIGHT AT THE TIME: 883 GRAMS. OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6FR TO SUCTION. THIS CAUSED AN EXTRA INTUBATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268726 ↗
• InjuryMay 8, 2024Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. FOR THIS REPORTED MALFUNCTION AT THE TIME OF THE EVENT THE PATIENT WAS 37 DAYS OLD; 28+1WEEKS CORRECTED. WEIGHT AT THE TIME: 723 GRAMS. OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6FR TO SUCTION. THIS CAUSED AN EXTRA INTUBATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268714 ↗
• InjuryMay 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. PATIENT WAS 0 DAYS OLD; 29+5 WEEKS CORRECTED. WEIGHT: 1390 (UNIT OF MEASURE NOT PROVIDED). OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO 6 FOR TO SUCTION. IT CAUSED EXTRA INTUBATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264624 ↗
• InjuryMay 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THE EVENT WAS FIRST NOTICED ON 11-FEB-2024. FOR THIS REPORTED EVENT THE PATIENT WAS 0 DAYS OLD; "29+6 WEEKS CORRECTED". "WEIGHT: 1329" (UNIT OF MEASURE NOT PROVIDED). OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6 FR TO SUCTION. IT CAUSED EXTRA INTUBATION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262852 ↗
• InjuryMay 7, 2024Defective Device; Gas/Air Leak; Defective Device; Gas/Air Leak

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6 FR TO SXN. IT CAUSED EXTRA INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260749 ↗
• InjuryMay 7, 2024Defective Device; Gas/Air Leak; Defective Device; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6 FR TO SXN. IT CAUSED EXTRA INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260489 ↗
• InjuryApr 29, 2024Defective Device; Gas/Air Leak; Defective Device; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THERE WAS PATIENT INVOLVEMENT (2EVENTS). OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO 6 FR TO SXN. IT CAUSED EXTRA INTUBATION. TWO EVENTS WERE REPORTED (EMDR-19934 AND EMDR-20613). THIS IS THE FIRST MALFUNCTION FOR THE RELATED REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202519 ↗
• InjuryApr 29, 2024Defective Device; Gas/Air Leak; Defective Device; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THERE WAS PATIENT INVOLVEMENT (2EVENTS). OUTCOME- INCREASED LEAK AROUND ETT AND 8FR SUCTION CATHETER CHANGED TO TO 6 FR TO SXN. IT CAUSED EXTRA INTUBATION. TWO EVENTS WERE REPORTED (EMDR-19934 AND EMDR-20613). THIS IS THE SECOND MALFUNCTION FOR THE RELATED REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202516 ↗
• MalfunctionApr 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT RECENT PRODUCTS APPEAR TO FEATURE A SMALLER DIAMETER THAN PREVIOUSLY. EVERY 3.0 ETT USED SINCE FEBRUARY HAS BEEN AFFECTED. NORMALLY THE 8FR SUCTION FITS EASILY THROUGH THE 3.0 ETT; HOWEVER, WITH USE IN CURRENT PRODUCTS, THEY WILL NOT ADVANCE BEYOND 14CM. THE REPORTED IS AWARE OF 5 INSTANCES ON PATIENTS, PLUS 2 SAMPLES STAFF TESTED. HOSPITAL IS NOW HAVING TO USE SMALLER SUCTION CATHETERS THAN STANDARD CARE ¿ CHANGED INLINE SUCTION CATHETER TO A 6 FRENCH. RT HAVE LOCATED OLDER PRODUCT WITHIN THE HOSPITAL AND CONFIRMED OLDER PRODUCT HAS NO ISSUE WITH DIAMETER SIZE. THE ISSUE WAS FIRST OBSERVED WITH PATIENTS, THEN A FEW UNITS WERE TESTED (NOT IN PATIENTS) TO CONFIRM THE ISSUE IN A MORE CONTROLLED SETTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125116 ↗
• InjuryApr 10, 2023Entrapment of Device; Difficult to Insert; Obstruction of Flow; Improper Flow or Infusion; Entrapment of Device; Difficult to Insert; Obstruction of Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH A 2.5 ENDOTRACHEAL TUBE BY THE PEDIATRICIAN. NOT VENTILATING APPROPRIATELY AND REQUIRING HIGH PRESSURES. REINTUBATED WITH 3.0 ENDOTRACHEAL TUBE PER ANESTHESIA. MEDICAL STAFF REMEMBER HAVING DIFFICULTY WITH THE STYLET PRE AND POST SECOND INTUBATION. VENTILATOR PRESSURES WERE STILL HIGH, SO THE BABY WAS REINTUBATED WITH A 3RD 3.0 ENDOTRACHEAL TUBE WITH IMPROVEMENT IN OXYGENATION AND PRESSURES. UPON REMOVAL OF THE SECOND ENDOTRACHEAL TUBE, IT APPEARED THAT THERE WAS A 2.0 ENDOTRACHEAL TUBE STUCK INSIDE THE 3.0 ENDOTRACHEAL TUBE. THERE HAS BEEN NO REPORT OF CLINICAL AFFECTS.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16709907 ↗
• InjuryMar 22, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE ET TUBE WAS DEFECTIVE (TUBE INSIDE OF THE TUBE) MAKING IT HARD TO VENTILATE. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16589361 ↗
• MalfunctionSep 14, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE TAPE HOLDING SECURE A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE (ETT), HAD REMOVED THE NUMBER MARKINGS. IT WAS REPORTED THAT THE CLINICIANS COULD NOT VISUALIZE WHERE THE ETT WAS SECURED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532099 ↗

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