Portex Z210-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019315046902), received between Jun 4, 2018 and Sep 2, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Use of Device Problem; Suction Problem; Use of Device Problem; Suction Problem

  IT WAS REPORTED THAT THE PATIENT'S OXYGEN SATURATION WAS LOW, AND THEY HAD THICK MUCUS/PHLEGM THAT NEEDED TO BE SANCTIONED, BUT THE INLINE CATHETER WAS ONLY ABLE TO MOVE ABOUT 1 INCH (WHERE LUMENS ATTACH TO T-PIECE CONNECTOR), AND THE PATIENT CONTINUED TO DESATURATE DUE TO THIS ISSUE. REPORTER STATED A NEW INLINE SUCTION CATHETER WAS USED AND ABLE TO CLEAR THE SPUTUM. THE PATIENT'S OXYGEN SATURATION STABILIZED AFTER.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22938968 ↗
• MalfunctionSep 4, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE SUCTION DOES NOT COUPLED IN TQT OR TOT WITH LEAKAGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353918 ↗
• MalfunctionSep 4, 2022Break; Break

  IT WAS REPORTED THAT THE CLOSE VENTILATION SUCTION SYSTEMS BROKE AT THE WHITE RING SEVERAL TIMES. IT WAS FURTHER REPORTED THAT THE BLUE CONTROL VALVE OF THE SYSTEMS BROKE AND NOT THE WHITE RING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353841 ↗
• MalfunctionSep 4, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INTRODUCE THE BIOPSY DEVICE DURING AN ALVEOLAR BIOPSY ON A PATIENT WHO WAS INTUBATED THE NIGHT BEFORE. IT WAS ALSO DIFFICULT TO RINSE WHEN NECESSARY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353839 ↗
• MalfunctionSep 4, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VOLUME WAS NOT DELIVERED DURING ASPIRATION AND ESPECIALLY DURING THE TIME OF FLUSHING OF THE TUBING VERY DIFFICULT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353835 ↗
• MalfunctionSep 4, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INTRODUCE THE BIOPSY DEVICE DURING AN ALVEOLAR BIOPSY ON A PATIENT WHO WAS INTUBATED THE NIGHT BEFORE. IT WAS ALSO DIFFICULT TO RINSE WHEN NECESSARY NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353834 ↗
• MalfunctionSep 4, 2022Stretched; Stretched

  IT WAS REPORTED THAT UPON THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE SLEEVE WAS EXPANDING BEFORE PERFORMING SUCTION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353831 ↗
• MalfunctionJun 10, 2021Backflow; Backflow

  INFORMATION RECEIVED A SMITHS MEDICAL SUCTIONPRO72 DL 14 20/CA SUCTION/PORTEX CATHETERS SUCTIONPRO 72 REPORT INDICATED WATER REMAINED IN THE DEVICE AND CREATED ALARM WITH THE VENTILATOR. THE DRIPPED DROPLET FROM THE END OF THE RING CONNECTOR, FACILITATED UNTIMELY DISASSEMBLY OF THE COUPLING (THE COUPLING IS NO LONGER CONNECTED AT ONE OF ITS ENDS) : THE VENTILATION CIRCUIT WAS OPEN. CONCERN FOR DECANNULATION OF VENTILATOR AND CONTAMINATION OF DROPLETS. REPORTED NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974527 ↗
• InjuryJun 13, 2018Suction Problem; Suction Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® SUCTIONPRO 72¿ SUCTIONED INEFFECTIVELY FOLLOWING 6 - 8 HOURS OF USE. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT'S LUNG COLLAPSED; LEADING TO A REQUIRED BRONCHOSCOPY BEING PERFORMED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Pneumothorax

  MAUDE report 7598821 ↗
• InjuryJun 4, 2018Decrease in Suction; Decrease in Suction

  INFORMATION WAS RECEIVED INDICATING THAT THIS CLOSED VENTILATION SUCTION SYSTEM DID NOT SUCTION EFFICIENTLY. THIS WAS DISCOVERED ABOUT 6-8 MINUTES AFTER USE. THE PATIENT SUFFERED A LUNG COLLAPSE AND REQUIRED BRONCHOSCOPY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 7567173 ↗