OPTITORQUE 40-5023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350703521), received between May 9, 2022 and Jul 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Material Twisted/Bent; Material Twisted/Bent

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES THAT THE DIAGNOSTIC RADIAL CATHETER BENT DURING ITS USE IN A PATIENT. IT WAS SUBSEQUENTLY REMOVED AND REPLACED, RESULTING IN NO HARM TO THE PATIENT. THE INCIDENT TOOK PLACE IN THE ELECTROPHYSIOLOGY LAB. ADDITIONAL INFORMATION WAS RECEIVED 19 JUN 2024: THERE WAS NO REPORTED TORTUOSITY THAT COULD HAVE AFFECTED CATHETER MANIPULATION WITHIN THE PATIENT. THE PATIENT'S CONDITION IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707872 ↗
• MalfunctionAug 24, 2023

  ELDERLY MALE WITH ACUTE SOB (SHORTNESS OF BREATH). PROCEDURE: DIAGNOSTIC HEART CATH. UPON REMOVING THE CATHETER FROM PACKAGING, THE CATHETER WAS KINKED AND UNABLE TO BE USED. 3 MORE CATHETERS WERE THE SAME WITH THE SAME LOT NUMBER. CATHETERS WERE STORED ON A SHELF, IN THE ORIGINAL BOX.. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, OPTITORQUE (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610695 ↗
• MalfunctionMay 9, 2022Material Twisted/Bent

  ADULT MALE WITH HISTORY OF HTN, STEMI AND RECENT SHORTNESS OF BREATH AND SWELLING OF LOWER EXTREMITIES. PROCEDURE: LEFT HEART CATH. TERUMO JACKEY RADIAL REMOVED FROM THE PACKAGE, IN THE ORIGINAL BOX THAT WAS KEPT ON A SHELF, AND HAD A BEND IN THE TUBING. NOT USED ON THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, OPTITORQUE (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: Insufficient Information

  MAUDE report 14336099 ↗