SUPER TORQUE 533556Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032012706), received between Sep 17, 2025 and Sep 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER: 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER: 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER: 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER: 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER: 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078116 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076848 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076819 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076800 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076638 ↗
• MalfunctionSep 17, 2025Degraded; Degraded

  AS REPORTED, BLUE PIECES AND CRACKING OF PLASTIC NEAR THE HUB WERE FOUND ON MULTIPLE DIAGNOSTIC CATHETERS, INCLUDING 5F JL3.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-518T), 5F JL4 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-520T), 5F JL4.5 SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-517T), 5F IM SUPER TORQUE PLUS DIAGNOSTIC CATHETERS (CATALOG NUMBER 534-560T), AND A 5.2F MP A2(I) 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER (CATALOG NUMBER 533-556). THE AFFECTED PRODUCTS WERE IDENTIFIED ACROSS MULTIPLE PACKAGES DURING STOCK INSPECTION, AND THE PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE DEVICES WILL BE RETURNED FOR EVALUATION. FOUR IMAGES WERE REVIEWED AND THE SHOW CATHETERS INSIDE THEIR PACKAGING. POLYMER FLAKES CAN BE SEEN INSIDE THE PACKAGING, AND THEY APPEAR TO HAVE ORIGINATED FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076487 ↗