SUPERTORQUE 533621Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032013048), received between May 7, 2024 and Mar 31, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionMar 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, DURING A CORONARY ANGIOGRAM, THE F6 ST+ JR 4 SUPERTORQUE DIAGNOSTIC CATHETER WAS FOUND TO NOT LOCK INTO MANIFOLD EXTENSION TUBING RESULTING IN INADEQUATE AND UNSAFE CONNECTION FOR INTRAARTERIAL/INTRACORONARY CONTRAST INJECTIONS. THE DAMAGE WAS NOTICED UPON CONNECTION PRIOR TO USE. THE CORDIS JR 4 100CM SUPER TORQUE PLUS WAS REMOVED FROM PROCEDURE, A NEW CORDIS JR 4 100CM SUPER TORQUE PLUS WAS PROVIDED, IT WAS FOUND TO CONNECT ADEQUATELY IN ORDER ALLOW CORONARY ANGIOGRAM TO PROCEED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED IN THE LAB BY HANGING ON A HOOK WITH THE PROVIDED HANGING POINT. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB, AND NO ANOMALIES WERE NOTED AT THIS TIME. THE DEVICE WAS PREPPED PER THE IFU. NO DIFFICULTY WAS EXPERIENCED IN PREPPING THE DEVICE. THE CATHETER WAS NOT ADVANCED THROUGH THE SHEATH, SO THERE WAS NO RESISTANCE OR FRICTION. NO EXCESS FORCE WAS USED DURING THE CASE. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729777 ↗
• InjuryMay 7, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A CORONARY ANGIOGRAPHY WAS PERFORMED ON A PATIENT VIA THE RADIAL ARTERY. UPON COMPLETION OF THE PROCEDURE, THE 6F JR4 SUPER TORQUE + CATHETER COULD NOT BE WITHDRAWN DUE TO COMPLICATIONS AT THE LEVEL OF THE RADIAL ARTERY (SPASM), DESPITE VARIOUS ATTEMPTS (PHARMACOLOGICAL, ANESTHETIC, ETC). VASOSPASM WAS CAUSED DUE TO THE PRESENCE OF THE CATHETER. THE CATHETER WAS REMOVED THROUGH A VASCULAR SURGEON. THE CATHETER WAS REMOVED DURING SURGERY (CUT DOWN). IT WAS NOTED THAT THE CATHETER DID NOT BREAK INTO TWO PIECES. THE CATHETER WAS CUT BY THE VASCULAR SURGEON AT 2 POINTS. 1. AT THE PUNCTURE SITE OF THE RADIAL ARTERY, 2. AT THE LEVEL OF THE BIFURCATION OF THE BRACHIAL ARTERY AFTER SURGICAL EXPOSURE) SO THAT IT COULD BE REMOVED FROM THE RADIAL ARTERY BY TRACTION, WHICH WAS ULTIMATELY ACHIEVED. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THERE WAS NO RESISTANCE/FRICTION WHILE ADVANCING THROUGH THE VESSEL. UNUSUAL FORCE WAS NOT NEEDED TO ADVANCE OR WITHDRAWAL THE CATHETER FROM THE PATIENT. THE INTENDED PROCEDURE WAS A CORONARY ANGIOGRAPHY. THE VESSEL DID NOT HAVE ANY TORTUOSITY. A GUIDEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259526 ↗