CORDIS 533552Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032012676), received between Jul 2, 2021 and Oct 21, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Crack; Crack

  AS REPORTED, THE HUB OF A 5.2F JUDKIN'S RIGHT (JR) 4 100CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER WAS CRACKED, MAKING IT IMPOSSIBLE TO ATTACH A SYRINGE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT UNIT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HUB WAS FOUND CRACKED AFTER OPENING THE DEVICE. THERE WAS NO REPORTED DAMAGE TO THE PACKAGING PRIOR TO OPENING, AND THE DEVICE WAS STORED AND PREPARED PER THE INSTRUCTIONS FOR USE. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB AND WAS NOT TORQUED OR STEERED BY IT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352457 ↗
• MalfunctionDec 2, 2024Leak/Splash; Leak/Splash

  AS REPORTED, LUER LOCK OF THE CORDIS F5.2+ JR4 100CM SUPER TORQUE ANGIOGRAPHIC CATHETER HAD A DEFECT WITH POTENTIAL LEAKAGE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE RETURNED DEVICES WERE TAKEN FROM THE SHELF BY THE CLINIC STAFF THEMSELVES. THE RETURNED DEVICES ARE STILL FRESHLY PACKAGED. THESE ARE STILL IN THEIR PACKAGING. THE DEVICES HAVE NOT UNPACKED OR TESTED TO SEE IF THEY ALSO HAVE ANY DAMAGE OR LEAKAGE. UNFORTUNATELY, WE DID NOT RECEIVE THE PRODUCTS THAT WERE ACTUALLY AFFECTED. ADDITIONAL INFORMATION WAS NOT RECEIVED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818191 ↗
• MalfunctionAug 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A HAIR STRAND WAS FOUND INSIDE OF THE STERILE PACKAGE OF THE 5.2F, 100CM SUPER TORQUE PLUS JUDKIN'S RIGHT (JR) 4 POLYURETHANE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CORDIS DIAGNOSTIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THE PACKAGE HAD NOT BEEN OPENED BY THE CUSTOMER. THE SEAL OF THE INNER PACKAGE HAD NOT BEEN OPENED. THE CONDITION WAS NOTED PRIOR TO USING THE PRODUCT, AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB. IT WAS STORED LIKE ALL OTHER PRODUCTS IN THE CATHETERIZATION LAB, WITH NO OTHER HAIRS DETECTED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907001 ↗
• MalfunctionAug 16, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, THE PROBE AT THE BASE OF THE 5.2F 100CM JUDKINS RIGHT (JR4) SUPERTORQUE PLUS ANGIOGRAPHIC CATHETER WAS BROKEN. PER VISUAL ANALYSIS THE HUB WAS FOUND TO BE CRACKED AND SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12326756 ↗
• InjuryJul 2, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 5.2F 100CM JUDKINS RIGHT (JR4) SUPERTORQUE PLUS DIAGNOSTIC CATHETER GOT KINKED/LOOPED INSIDE THE RIGHT RADIAL ARTERY (ABOUT 30 CM FROM THE HUB) AND COULDN'T BE REMOVED FROM THE PATIENT. THE PATIENT HAD TO GO TO THE OR IN ORDER TO REMOVE THE CATHETER. THE OPERATOR WAS A TRAINED USER OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108077 ↗