SUPERTORQUE PLUS 533532Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032012546), received between Jan 31, 2025 and Jan 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 31, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, TWO 5FR MP A2 SUPERTORQUE PLUS CATHETERS CRACKED AT THE HUB WHEN A SYRINGE WAS ATTACHED. THE DEVICES WERE NOT USED IN THE PATIENT AS THE CRACK WAS NOTICED WHEN THE SYRINGE WAS ATTACHED FOR FLUSHING. THE PROCEDURE WAS COMPLETED BY OPENING AND USING A NEW MPA2 CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING THEM FROM THE PACKAGING. NO OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCTS INTO THE PATIENT. THE DEVICES PREPPED NORMALLY, WITH A SYRINGE ATTACHED TO THE CATHETERS (X2) FOR FLUSHING. THE INTENDED PROCEDURE WAS A RIGHT HEART CATHETERIZATION FOR BLOOD SAMPLING, TARGETING NORMAL PA¿S, WITH NO CALCIFICATION IN A PEDIATRIC PATIENT. THE VESSEL HAD NO TORTUOSITY. THE SYRINGE WAS NOT TORQUED AGAINST RESISTANCE WHEN ATTACHING TO THE CATHETER. AND THE SECOND DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE FIRST DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282405 ↗
• MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, TWO 5FR MP A2 SUPERTORQUE PLUS CATHETERS CRACKED AT THE HUB WHEN A SYRINGE WAS ATTACHED. THE DEVICES WERE NOT USED IN THE PATIENT AS THE CRACK WAS NOTICED WHEN THE SYRINGE WAS ATTACHED FOR FLUSHING. THE PROCEDURE WAS COMPLETED BY OPENING AND USING A NEW MPA2 CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING THEM FROM THE PACKAGING. NO OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCTS INTO THE PATIENT. THE DEVICES PREPPED NORMALLY, WITH A SYRINGE ATTACHED TO THE CATHETERS (X2) FOR FLUSHING. THE INTENDED PROCEDURE WAS A RIGHT HEART CATHETERIZATION FOR BLOOD SAMPLING, TARGETING NORMAL PA¿S, WITH NO CALCIFICATION IN A PEDIATRIC PATIENT. THE VESSEL HAD NO TORTUOSITY. THE SYRINGE WAS NOT TORQUED AGAINST RESISTANCE WHEN ATTACHING TO THE CATHETER. AND THE SECOND DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE FIRST DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282352 ↗