SUPER TORQUE 533693Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032013574), received between May 4, 2025 and May 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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. 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.

• MalfunctionMay 4, 2025Degraded; Degraded

  AS REPORTED, THE DOCTOR NOTICED THAT THE SHORT PORTION JUST BELOW THE HUB ON THE 6FR MPAC SUPER TORQUE CATHETER HAD CRUMBLED INTO SMALL PIECES. THE TEAM PULLED ANOTHER 6FR MPAC SUPER TORQUE, AND UPON INSPECTION, SAW THAT IT HAD A DEFECT IN THE SAME PLACE AS THE CRUMBLED CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A ROUTINE HEART CATHETERIZATION. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE STORED ON A HANGER BEHIND A GLASS DOOR. THE DEVICE RECEIVES FLUORESCENT LIGHT EXPOSURE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT DOORS (GLASS). THE SHIPMENT OF DEVICES IS NOT STORED IN AN ENVIRONMENT THAT IS NOT CLIMATE CONTROLLED AT ANY POINT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS NOT EXPOSED TO UV LIGHTING OR ANY FORM OF STERILIZATION PROCESS AT ANY POINT. THE LAB DOES NOT USE ANY SORT OF UV OR STERILIZATION PROCESS IN GENERAL. THE DEVICE WILL BE RETURNED FOR EVALUATION. TWO IMAGES WERE PROVIDED. THE FIRST IMAGE SHOWS THE PROXIMAL PORTION OF A CATHETER, WITH ALL BUT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955956 ↗
• MalfunctionMay 4, 2025Degraded; Degraded

  AS REPORTED, THE DOCTOR NOTICED THAT THE SHORT PORTION JUST BELOW THE HUB ON THE 6FR MPAC SUPER TORQUE CATHETER HAD CRUMBLED INTO SMALL PIECES. THE TEAM PULLED ANOTHER 6FR MPAC SUPER TORQUE, AND UPON INSPECTION, SAW THAT IT HAD A DEFECT IN THE SAME PLACE AS THE CRUMBLED CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A ROUTINE HEART CATHETERIZATION. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE STORED ON A HANGER BEHIND A GLASS DOOR. THE DEVICE RECEIVES FLUORESCENT LIGHT EXPOSURE WHEN STORED. THE DEVICES ARE NOT STORED IN THE WHITE OUTER BOX UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS WITH TRANSPARENT DOORS (GLASS). THE SHIPMENT OF DEVICES IS NOT STORED IN AN ENVIRONMENT THAT IS NOT CLIMATE CONTROLLED AT ANY POINT BEFORE BEING STORED IN THE LAB. THE DEVICE IS NOT REPROCESSED OR RE-STERILIZED. THE DEVICE IS NOT EXPOSED TO UV LIGHTING OR ANY FORM OF STERILIZATION PROCESS AT ANY POINT. THE LAB DOES NOT USE ANY SORT OF UV OR STERILIZATION PROCESS IN GENERAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955953 ↗