Portex 197-35RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315058554), received between Jan 4, 2023 and Jan 4, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT THERE WAS DEFORMATION ON INSIDE PACKING WITH OUTER CARTON INTACT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097295 ↗
• MalfunctionJan 4, 2023Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT THERE WAS DEFORMATION ON INSIDE PACKING WITH OUTER CARTON INTACT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096933 ↗