SUPERTORQUE 532642Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032012164), received between Mar 28, 2024 and Jun 1, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2024Degraded; Flaked; Degraded; Flaked

  AS REPORTED, THERE WERE BLUE FLAKES FOUND WITHIN THE PACKAGING OF A 6F MULTI-PURPOSE (MP) A2 100CM 2 SIDE-HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER. THE USER PUT IT TO THE SIDE TO GIVE TO SUPPLY AND PROCEEDED TO GET ANOTHER CATHETER OF THE SAME SIZE AND CURVE. HE INSPECTED THE PACKAGING AND NOTICED NO DEFECTS. HE HANDLED OFF THE CATHETER TO A STERILE TECHNICIAN. DURING THE CARDIAC CATHETERIZATION PROCEDURE UNDER X-RAY, THE PROVIDER FELT SOMETHING ON HIS HANDS. HE LOOKED DOWN AT HIS HANDS AND NOTICED BLUE PLASTIC FLAKES ON HIS STERILE GLOVES. WHEN THE LIGHTS CAME ON (AS THEY TURN OFF WHEN USING X-RAYS) THERE WAS BLUE PLASTIC FLAKES ON THE STERILE FIELD. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROVIDER CHANGED OUT HIS STERILE GLOVES AND PROCEEDED TO REMOVE THE CATHETER THAT WAS IN THE RIGHT HEART ATRIUM. HE DID THIS AS PRECAUTION SINCE THE BLUE FLAKES WERE THE SAME COLOR OF THE CATHETER THAT WAS REMOVED. THE STERILE TEAM INSPECTED THE FIELD AND REMOVED ANY PARTICLES FROM THE FIELD. THE ENTIRE ITEM LOT WAS REMOVED FROM INVENTORY. AT THE TWO WEEKS POST-OP APPOINTMENT, THE PATIENT COMPLAINED OF A BRIEF 1-HOUR BLURRINESS SINCE THE PROCEDURE. SHE DID NOT SEEK OUT ANY MEDICAL CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443468 ↗
• MalfunctionJun 1, 2024Degraded; Flaked; Degraded; Flaked

  AS REPORTED, THERE WERE BLUE FLAKES FOUND WITHIN THE PACKAGING OF A 6F MULTI-PURPOSE (MP) A2 100CM 2 SIDE-HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER. THE USER PUT IT TO THE SIDE TO GIVE TO SUPPLY AND PROCEEDED TO GET ANOTHER CATHETER OF THE SAME SIZE AND CURVE. HE INSPECTED THE PACKAGING AND NOTICED NO DEFECTS. HE HANDLED OFF THE CATHETER TO A STERILE TECHNICIAN. DURING THE CARDIAC CATHETERIZATION PROCEDURE UNDER X-RAY, THE PROVIDER FELT SOMETHING ON HIS HANDS. HE LOOKED DOWN AT HIS HANDS AND NOTICED BLUE PLASTIC FLAKES ON HIS STERILE GLOVES. WHEN THE LIGHTS CAME ON (AS THEY TURN OFF WHEN USING X-RAYS) THERE WAS BLUE PLASTIC FLAKES ON THE STERILE FIELD. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROVIDER CHANGED OUT HIS STERILE GLOVES AND PROCEEDED TO REMOVE THE CATHETER THAT WAS IN THE RIGHT HEART ATRIUM. HE DID THIS AS PRECAUTION SINCE THE BLUE FLAKES WERE THE SAME COLOR OF THE CATHETER THAT WAS REMOVED. THE STERILE TEAM INSPECTED THE FIELD AND REMOVED ANY PARTICLES FROM THE FIELD. THE ENTIRE ITEM LOT WAS REMOVED FROM INVENTORY. AT THE TWO WEEKS POST-OP APPOINTMENT, THE PATIENT COMPLAINED OF A BRIEF 1-HOUR BLURRINESS SINCE THE PROCEDURE. SHE DID NOT SEEK OUT ANY MEDICAL CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441989 ↗
• MalfunctionMay 31, 2024Degraded; Flaked; Degraded; Flaked

  AS REPORTED, THERE WERE BLUE FLAKES FOUND WITHIN THE PACKAGING OF A 6F MULTI-PURPOSE (MP) A2 100CM 2 SIDE-HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER. THE USER PUT IT TO THE SIDE TO GIVE TO SUPPLY AND PROCEEDED TO GET ANOTHER CATHETER OF THE SAME SIZE AND CURVE. HE INSPECTED THE PACKAGING AND NOTICED NO DEFECTS. HE HANDLED OFF THE CATHETER TO A STERILE TECHNICIAN. DURING THE CARDIAC CATHETERIZATION PROCEDURE UNDER X-RAY, THE PROVIDER FELT SOMETHING ON HIS HANDS. HE LOOKED DOWN AT HIS HANDS AND NOTICED BLUE PLASTIC FLAKES ON HIS STERILE GLOVES. WHEN THE LIGHTS CAME ON (AS THEY TURN OFF WHEN USING X-RAYS) THERE WAS BLUE PLASTIC FLAKES ON THE STERILE FIELD. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROVIDER CHANGED OUT HIS STERILE GLOVES AND PROCEEDED TO REMOVE THE CATHETER THAT WAS IN THE RIGHT HEART ATRIUM. HE DID THIS AS PRECAUTION SINCE THE BLUE FLAKES WERE THE SAME COLOR OF THE CATHETER THAT WAS REMOVED. THE STERILE TEAM INSPECTED THE FIELD AND REMOVED ANY PARTICLES FROM THE FIELD. THE ENTIRE ITEM LOT WAS REMOVED FROM INVENTORY. AT THE TWO WEEKS POST-OP APPOINTMENT, THE PATIENT COMPLAINED OF A BRIEF 1-HOUR BLURRINESS SINCE THE PROCEDURE. SHE DID NOT SEEK OUT ANY MEDICAL CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441595 ↗
• MalfunctionMar 28, 2024Degraded; Flaked; Detachment of Device or Device Component; Degraded; Flaked; Detachment of Device or Device Component

  AS REPORTED, THERE WERE BLUE FLAKES FOUND WITHIN THE PACKAGING OF A 6F MULTI-PURPOSE (MP) A2 100CM 2 SIDE-HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER. THE USER PUT IT TO THE SIDE TO GIVE TO SUPPLY AND PROCEEDED TO GET ANOTHER CATHETER OF THE SAME SIZE AND CURVE. HE INSPECTED THE PACKAGING AND NOTICED NO DEFECTS. HE HANDLED OFF THE CATHETER TO A STERILE TECHNICIAN. DURING THE CARDIAC CATHETERIZATION PROCEDURE UNDER X-RAY, THE PROVIDER FELT SOMETHING ON HIS HANDS. HE LOOKED DOWN AT HIS HANDS AND NOTICED BLUE PLASTIC FLAKES ON HIS STERILE GLOVES. WHEN THE LIGHTS CAME ON (AS THEY TURN OFF WHEN USING X-RAYS) THERE WAS BLUE PLASTIC FLAKES ON THE STERILE FIELD. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROVIDER CHANGED OUT HIS STERILE GLOVES AND PROCEEDED TO REMOVE THE CATHETER THAT WAS IN THE RIGHT HEART ATRIUM. HE DID THIS AS PRECAUTION SINCE THE BLUE FLAKES WERE THE SAME COLOR OF THE CATHETER THAT WAS REMOVED. THE STERILE TEAM INSPECTED THE FIELD AND REMOVED ANY PARTICLES FROM THE FIELD. THE ENTIRE ITEM LOT WAS REMOVED FROM INVENTORY. AT THE TWO WEEKS POST-OP APPOINTMENT, THE PATIENT COMPLAINED OF A BRIEF 1-HOUR BLURRINESS SINCE THE PROCEDURE. SHE DID NOT SEEK OUT ANY MEDICAL CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991946 ↗