SUPERTORQUE 532515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032011778), received between Jul 16, 2019 and Jul 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJul 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THERE WAS DIFFICULTY ATTACHING A LUER LOCK SYRINGE TO TWO 5F SUPER TORQUE ANGIOGRAPHIC CATHETERS PRIOR TO USE. THE OPERATOR STATES THAT WHEN THEY LOOKED AT ONE OF THE DEVICES, IT DOES SEEM LIKE THERE ARE NO THREADS ON IT. WITH THE FIRST CATHETER, THE OPERATOR WAS NOT ABLE TO PROPERLY FLUSH (POOR CONNECTION), SO THE OPERATOR SWITCHED TO ANOTHER CATHETER OF THE SAME KIND AND WAS ABLE TO FLUSH BUT WITH DIFFICULTY AS THE SYRINGE DID NOT ATTACH SECURELY. THERE WAS NO PATIENT INJURY. BOTH CATHETERS WERE OF THE SAME LOT NUMBER. THE SYRINGE USED WAS NON-CORDIS. THE OPERATOR IS EXPERIENCED. THE PRODUCTS WERE STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE TAKEN OUT OF THEIR PACKAGES. THE DEVICES WERE PULLED FROM THEIR PACKAGING BY THE HUBS AND NO ANOMALIES WERE NOTED AT THAT TIME. THE PROCEDURE WAS COMPLETED USING A DIFFERENT UNKNOWN CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793290 ↗
• MalfunctionJul 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THERE WAS DIFFICULTY ATTACHING A LUER LOCK SYRINGE TO TWO 5F SUPER TORQUE ANGIOGRAPHIC CATHETERS PRIOR TO USE. THE OPERATOR STATES THAT WHEN THEY LOOKED AT ONE OF THE DEVICES IT DOES SEEM LIKE THERE ARE NO THREADS ON IT. WITH THE FIRST CATHETER THE OPERATOR WAS NOT ABLE TO PROPERLY FLUSH (POOR CONNECTION) SO THE OPERATOR SWITCHED TO ANOTHER CATHETER OF THE SAME KIND AND WAS ABLE TO FLUSH BUT WITH DIFFICULTY AS THE SYRINGE DID NOT ATTACH SECURELY. THERE WAS NO PATIENT INJURY. BOTH CATHETERS WERE OF THE SAME LOT NUMBER. THE SYRINGE USED WAS NON-CORDIS. THE OPERATOR IS EXPERIENCED. THE PRODUCTS WERE STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE TAKEN OUT OF THEIR PACKAGES. THE DEVICES WERE PULLED FROM THEIR PACKAGING BY THE HUBS AND NO ANOMALIES WERE NOTED AT THAT TIME. THE PROCEDURE WAS COMPLETED USING A DIFFERENT UNKNOWN CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793213 ↗