SUPERTORQUE 532502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032011655), received between Jan 20, 2023 and Sep 25, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902791 ↗
• MalfunctionSep 25, 2026Detachment of Device or Device Component

  As reported, the hub of two 5F Simmons (SIM) 2 100cm SUPER TORQUE diagnostic catheters came off during a procedure. There was no reported patient injury. The devices were opened in a sterile field, used in the same patient, and stored according to the labeling. The devices will be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892870 ↗
• InjuryJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F SIDEWINDER SIMMONS II (SIM2) SUPER TORQUE DIAGNOSTIC CATHETER WAS ATTEMPTED TO BE ADJUSTED WHEN IT GOT UP TO THE BRACHIOCEPHALIC ARTERY AND CATHETER WAS NOT RESPONDING. THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS LOOKED AT AND SAW THE CATHETER WAS KINKED. IT WAS ATTEMPTED TO UNKINK THE CATHETER BY TWISTING A LITTLE BIT BUT IT WAS NOTICED THE CATHETER THEN BROKE OFF. THE PROXIMAL PORTION OF THE SIM2 SUPER TORQUE CATHETER WAS RETRIEVED AND REMOVED. THEN, THE PIECE THAT HAD BROKEN OFF WAS REMOVED BY VASCULAR SURGERY WITH AN UNKNOWN SNARE ENDOVASCULARLY. THERE WAS NOT REPORTED PATIENT INJURY NOR WAS THERE PERMANENT DAMAGE. THE ACCESS SITE WAS RCFA AND THE PROXIMAL RCFA HAD TORTUOSITY, 360 DEGREE LOOP AND HAD NO STENOSIS NOR CALCIFICATION. THIS WAS A DIAGNOSTIC CASE WHERE THE LESIONS WERE THE RIGHT COMMON CAROTID ARTERY AND BRACHIOCEPHALIC ARTERY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE PRODUCT WAS PREPPED ACCORDING TO THE IFU. NO OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218988 ↗