CORDIS 502101DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705032064712), received between Jun 14, 2022 and Nov 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Leak/Splash; Leak/Splash

  AS REPORTED, WHILE THE PATIENT WAS HAVING AN AORTOGRAM PROCEDURE, CONTRAST MEDIUM LEAKED THROUGH THE CONNECTION THAT GOES TO THE CATHETER OF THE INJECTOR EXTENSION OF THE 65 CM CATHETER EXTENSION TUBING. THE DAMAGE WAS NOTICED AT THE TIME OF THE CONTRAST MEDIUM INJECTION. IT LEAKED AT A FEMALE CONNECTION POINT AND IT WAS CHANGED FOR ANOTHER EXTENSION WHICH HAD THE SAME PROBLEM. ANOTHER CORDIS EXTENSION WAS PASSED AND IT WORKED WITHOUT ANY PROBLEM. THE PROCEDURE WAS CARRIED OUT WITHOUT ANY FURTHER COMPLICATIONS AND THE PATIENT LEFT IN PERFECT CONDITION. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES NOTED TO THE DEVICES. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610098 ↗
• MalfunctionNov 5, 2024Leak/Splash; Leak/Splash

  AS REPORTED, WHILE THE PATIENT WAS HAVING AN AORTOGRAM PROCEDURE, CONTRAST MEDIUM LEAKED THROUGH THE CONNECTION THAT GOES TO THE CATHETER OF THE INJECTOR EXTENSION OF THE 65 CM CATHETER EXTENSION TUBING. THE DAMAGE WAS NOTICED AT THE TIME OF THE CONTRAST MEDIUM INJECTION. IT LEAKED AT A FEMALE CONNECTION POINT AND IT WAS CHANGED FOR ANOTHER EXTENSION WHICH HAD THE SAME PROBLEM. ANOTHER CORDIS EXTENSION WAS PASSED AND IT WORKED WITHOUT ANY PROBLEM. THE PROCEDURE WAS CARRIED OUT WITHOUT ANY FURTHER COMPLICATIONS AND THE PATIENT LEFT IN PERFECT CONDITION. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES NOTED TO THE DEVICES. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609553 ↗
• MalfunctionSep 3, 2024Leak/Splash; Leak/Splash

  DURING AORTOGRAM PROCEDURES IN HAEMODYNAMIC LABORATORIES, WHEN USING THE 65 CM CATHETER EXTENSION TUBING FOR THE INJECTOR, IT DID NOT WORK PROPERLY, CAUSING A LEAK OF CONTRAST MEDIUM, WHEN CONNECTING IT TO THE INJECTOR AND STARTING TO INJECT. THIS REQUIRED THE USE OF A SECOND DEVICE THAT HAD THE SAME FAULT. THE SITUATION WAS CORRECTED BY USING A THIRD DEVICE, WHICH WORKED CORRECTLY, WITHOUT CAUSING ANY HARM TO THE PATIENT. THERE WAS NO DEVICE DAMAGE NOTED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125374 ↗
• MalfunctionSep 3, 2024Leak/Splash; Leak/Splash

  THE DEVICES WERE NOT RETURNED FOR EVALUATION AS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125283 ↗
• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 65CM 1200PSI CATHETER EXTENSION TUBING WAS RELEASED WHILE THE METAL PART REMAINED CONNECTED TO A NON-CORDIS CATHETER THAT WAS BEING USED DURING THIS PROCEDURE AND THE TUBING WAS SEPARATED. AS A RESULT, A NEW 65CM 1200PSI CATHETER EXTENSION TUBING WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. NO ANGIOGRAMS WERE TAKEN WITH THE EXTENSION TUBING PRIOR TO THE DAMAGE OBSERVED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407197 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER AN ANGIOGRAPHIC POWER INJECTION WITH A NON-CORDIS POWER INJECTOR, THE METAL CIRCULAR PIECE OF A 65CM 1200PSI CATHETER EXTENSION TUBING DETACHED FROM THE DISTAL END OF THE TUBING EXTENSION AS THE DEVICE WAS BEING DISCONNECTED. AS A RESULT, ANOTHER CORDIS 65CM EXTENSION TUBING WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED, AND THE DEVICE BECAME SEPARATED WHEN BEING DISCONNECTED AFTER POWER INJECTION VIA THE NON-CORDIS POWER INJECTOR. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN ANGIOPLASTY PROCEDURE. THE DEVICES WERE BEING USED BY AN EXPERIENCED USER AND THERE WERE NO ISSUES PREPPING EITHER DEVICE OR CONNECTING THE DEICES TO THE NON-CORDIS POWER INJECTOR. INFORMATION REGARDING THE PATIENT AND POWER INJECTION SETTINGS WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A SEPARATION OF THE FIRST EXTENSION TUBING THAT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514085 ↗
• MalfunctionJun 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ATTEMPTED MECHANICAL POWER INJECTION OF CONTRAST, THE METAL CIRCULAR PIECE OF A 65CM 1200PSI CATHETER EXTENSION TUBING DETACHED FROM THE DISTAL END OF THE TUBING EXTENSION. AS A RESULT, ANOTHER CORDIS 65CM EXTENSION TUBING WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN ANGIOPLASTY PROCEDURE. INFORMATION REGARDING THE PATIENT, POWER INJECTION SETTINGS, AND POTENTIAL ADDITIONAL RELATED COMPLAINTS WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A SEPARATION OF THE EXTENSION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787018 ↗
• MalfunctionJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE ENDS OF THE CATHETER EXTENSION (CCS CATH EXTEN 65CM 1200PSI) HAVE SHEARED OFF AT THE POINT OF WHERE THEY SCREW INTO THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION. THE EVENT INVOLVED TWO (2) DEVICES BOTH WITH THE SAME LOT NUMBER. THE METAL PIECE DID NOT BECOME DETACHED AND THE DEVICES WERE NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14729617 ↗
• MalfunctionJun 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE ENDS OF THE CATHETER EXTENSION (CCS CATH EXTEN 65CM 1200PSI) HAVE SHEARED OFF AT THE POINT OF WHERE THEY SCREW INTO THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION. THE EVENT INVOLVED TWO (2) DEVICES BOTH WITH THE SAME LOT NUMBER. THE METAL PIECE DID NOT BECOME DETACHED AND THE DEVICES WERE NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684623 ↗