SUPERTORQUE 532508Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032011709), received between Jan 2, 2019 and Jan 2, 2019 — classified as 2 malfunctions.

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

• MalfunctionJan 2, 2019Crack; Crack

  DURING USE OF THE ANGIOGRAPHIC MULTIPURPOSE SUPER TORQUE CATHETER FOR TRANSARTERIAL CHEMOEMBOLIZATION, THE PHYSICIAN REPORTED THAT THE CATHETER WAS STUCK IN THE ARTERY AND THEN THE HUB WAS BROKEN (CRACKED) DURING INFUSION. ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS RESISTANCE WITH THE GUIDEWIRE. THERE WAS NO PATIENT INJURY. THE DEVICES WERE REMOVED SUCCESSFULLY BUT WITH SOME DIFFICULTY. IT HAPPENED WITH TWO CATHETERS WITH THE SAME LOT NUMBERS. THE TARGET WAS ARTERIA HEPATICA WHICH WAS SLIGHTLY TORTUOUS AND THE LESION WAS TREATED FOR TOTAL CHRONIC OCCLUSION IN THE PAST THREE MONTH. THE DEVICES WERE PREPPED PER THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS NOTED. A RADIAL APPROACH WAS USED. A CONTRALATERAL APPROACH WASN'T USED. THERE WERE NO DIFFICULTY TRACKING THE DEVICE TOWARDS THE LESION OR THROUGH THE VESSEL. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE DEVICE WAS STORED IN THE CATH LAB PER THE IFU. THE PRODUCT WAS NOT RETURNED BUT IS AVAILABLE AS THE LAB HAS THE SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207918 ↗
• MalfunctionJan 2, 2019Crack; Difficult to Remove; Crack; Difficult to Remove

  DURING USE OF THE ANGIOGRAPHIC MULTIPURPOSE SUPER TORQUE CATHETER FOR TRANSARTERIAL CHEMOEMBOLIZATION, THE PHYSICIAN REPORTED THAT THE CATHETER WAS STUCK IN THE ARTERY AND THEN THE HUB WAS BROKEN (CRACKED) DURING INFUSION. ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS RESISTANCE WITH THE GUIDEWIRE. THERE WAS NO PATIENT INJURY. THE DEVICES WERE REMOVED SUCCESSFULLY BUT WITH SOME DIFFICULTY. IT HAPPENED WITH TWO CATHETERS WITH THE SAME LOT NUMBERS. THE TARGET WAS ARTERIA HEPATICA WHICH WAS SLIGHTLY TORTUOUS AND THE LESION WAS TREATED FOR TOTAL CHRONIC OCCLUSION IN THE PAST THREE MONTH. THE DEVICES WERE PREPPED PER THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS NOTED. A RADIAL APPROACH WAS USED. A CONTRALATERAL APPROACH WASN'T USED. THERE WERE NO DIFFICULTY TRACKING THE DEVICE TOWARDS THE LESION OR THROUGH THE VESSEL. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE DEVICE WAS STORED IN THE CATH LAB PER THE IFU. THE PRODUCT WAS NOT RETURNED BUT IS AVAILABLE AS THE LAB HAS THE SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207916 ↗