SUPER TORQUE 533533Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032012553), received between Jul 8, 2022 and Sep 17, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionSep 17, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  AS REPORTED, A SMALL FRAGMENT OF THE WHITE BASE OF THE LEAD OF A 5F 100CM INFINITI PIGTAIL DIAGNOSTIC CATHETER JUDKINS LEFT (JL) WITH SIDE HOLES (SH) ALMOST WENT INTO CIRCULATION DURING INJECTION OF CONTRAST AGENT. THE SMALL, WHITE FRAGMENT WAS FINALLY RECOVERED ON THE SPOT, BUT IT INITIALLY ALMOST WENT INTO CIRCULATION WITH THE RISK OF EMBOLUS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED DURING A CORONARY ANGIOGRAPHY EXAMINATION AND THE ISSUE OCCURRED DURING INJECTION OF CONTRAST AGENT TO OPACIFY THE LEFT VENTRICLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238659 ↗
• MalfunctionJul 8, 2022Crack; Detachment of Device or Device Component; Device-Device Incompatibility; Crack; Detachment of Device or Device Component; Device-Device Incompatibility

  AS REPORTED, THE HUB OF A 5.2F STRAIGHT PIGTAIL 110CM 6 SIDE HOLE (SH) SUPER TORQUE PLUS DIAGNOSTIC CATHETER SNAPPED OFF WHEN A NON-CORDIS HIGH-PRESSURE LINE WAS CONNECTED TO IT AND ACTUALLY CRACKED/BROKE. THE PLASTIC HUB AT PROXIMAL END OF CATHETER SNAPPED WHEN BEING ATTACHED TO THE FLUSH LINE. CATHETER WAS REMOVED WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED BY INSERTING A NEW UNKNOWN CATHETER AND A NON-CORDIS PRESSURE TUBING WAS ALSO REPLACED ALTHOUGH NOT DAMAGED DURING INITIAL INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. THE CASE WAS A ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THIS OCCURRED DURING AN ATTEMPT TO PERFORM A LEFT VENTRICULAR (LV) FLUSH STUDY. NO OBVIOUS EXTERNAL FAULT IDENTIFIED WITH CATHETER PRIOR TO USE. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE NOR EXCESSIVE TORQUEING WAS REQUIRED. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961097 ↗