Verrata Pressure Guide Wire 185cm JTIP 10185JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845225002442), received between Sep 29, 2018 and Sep 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, BEFORE NORMALIZATION, THE PHYSICIAN REALIZED THE TIP OF THE MANUFACTURE'S DEVICE WAS DAMAGED AND HE HAD TO REPLACE IT WITH ANOTHER SAME PRODUCT. THERE WAS NO STATUS DECLINE, EVIDENCE OF ANY INJURY OR ANY REQUIRED INTERVENTION TO PREVENT INJURY. BY REPORT, THE DEVICE APPEARED INTACT/IN ONE PIECE UPON REMOVAL FROM THE PATIENT. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND THE DISTAL PORTION OF THE SENSOR WAS MISSING. THE PROBABLE CAUSE FOR THE REPORTED "THE WIRE OF THE TIP WAS DAMAGED" FAILURE IS DAMAGE DURING USE. THE DAMAGE LIKELY OCCURRED AS A RESULT OF MECHANICAL STRAIN DURING PROCEDURE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A COMPONENT OF THE DEVICE IS MISSING AND IT COULD NOT BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921187 ↗