Portex Z115-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315035395), received between Sep 4, 2022 and Oct 1, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionOct 1, 2024Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  IT WAS REPORTED THAT THE SUCTION CATHETERS STOP SUCTIONING AS THE BLUE STOPPER BECOMES DETACHED AND BLOCKS FLOW. IT HAPPENS ESPECIALLY WHEN SPUTUM SECRETIONS ARE THICK AND CANNOT BE REPLICATED WITH SALINE OR THIN SECRETIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347258 ↗
• MalfunctionOct 1, 2024Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  IT WAS REPORTED THAT THE SUCTION CATHETERS STOP SUCTIONING AS THE BLUE STOPPER BECOMES DETACHED AND BLOCKS FLOW. IT HAPPENS ESPECIALLY WHEN SPUTUM SECRETIONS ARE THICK AND CANNOT BE REPLICATED WITH SALINE OR THIN SECRETIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346999 ↗
• MalfunctionOct 1, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT SUCTION CATHETERS STOP SUCTIONING AS THE BLUE STOPPER BECOMES DETACHED AND BLOCKS FLOW. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346789 ↗
• MalfunctionMay 16, 2024Complete Blockage; Disconnection; Complete Blockage; Disconnection

  IT WAS REPORTED THE RUBBER STOPPER GOT DETACHED AND WAS SUCK BACK TO THE OFF POSITION. THIS WAS BLOCKING THE SUCTION. THE EVENT OCCURRED IN THE HOSPITAL DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED. ONE OPENED DEVICE HAS BEEN RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332959 ↗
• MalfunctionMay 16, 2024Complete Blockage; Disconnection; Complete Blockage; Disconnection

  IT WAS REPORTED THE RUBBER STOPPER GOT DETACHED AND WAS SUCK BACK TO THE OFF POSITION. THIS WAS BLOCKING THE SUCTION. THE EVENT OCCURRED IN THE HOSPITAL DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331582 ↗
• MalfunctionSep 4, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CATHETER WAS TWISTED CAUSING DISCOMFORT TO PATIENT WHEN SUCTIONING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353850 ↗