SUPER TORQUE 533551Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032012669), received between Jan 7, 2022 and Aug 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE WHITE TIP OF A 5.2F JUDKINS LEFT 3.5 (JL3.5) SUPER TORQUE PLUS DIAGNOSTIC CATHETER BROKE. THERE WAS NO REPORTED PATIENT INJURY. PER PRELIMINARY IMAGE REVIEW, PICTURES OF THE DEVICE SHOW THAT THE HUB OF THE CATHETER WAS BROKEN INTO SEPARATE PIECES. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853866 ↗
• MalfunctionJun 11, 2022Device Difficult to Setup or Prepare; Material Puncture/Hole

  AS REPORTED, WHEN THE SUPER TORQUE CATHETER (CATH F5.2+ JL3.5 100CM) WAS BEING PREPARED BEFORE INSERTION, THE CUSTOMER NOTICED A HOLE IN THE BODY OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTED ON THE CATHETER (BODY/SHAFT AND DESCRIBED AS PUNCTURE/CUT. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED. THE DEVICE IS EXPECTED TO BE RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670633 ↗
• MalfunctionJan 7, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED, A 5F JUDKINS LEFT 3.5 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER LEAKED EXTERNALLY INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE INCIDENT EXTENDED THE PROCEDURE NO MORE THAN 15 MINUTES. THE PROCEDURE WAS A CORONARY ANGIOGRAPHY. THE INTENDED VESSEL WAS THE MIDDLE ANTERIOR INTERVENTRICULAR ARTERY. THIS WAS NOT FOR A CTO. THE VESSEL DIAMETER WAS 3MM WITH NORMAL CORONARY FLOW BUT HAD A VERY TIGHT STENOSIS. THE PERCENTAGE OF STENOSIS WAS 70-90%. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE NOR DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUEING WAS NOT REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK AT ANY PART. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190406 ↗