Portex 101/815/060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517077339), received between Feb 10, 2022 and Jul 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE EXTERNAL INFLATION CUFF HAD CAME OFF TWICE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368453 ↗
• MalfunctionFeb 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE STARTED LEAKING AFTER BEING REMOVED FROM THE BOX DURING PREPARATION OF INSERTION INTO PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514702 ↗
• MalfunctionFeb 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE STARTED LEAKING AFTER BEING REMOVED FROM THE BOX DURING PREPARATION OF INSERTION INTO PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514587 ↗
• MalfunctionFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE STARTED LEAKING AFTER REMOVING IT FROM THE BOX AND PREPARING TO PLACE INTO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508884 ↗