FlexCath Contour™ 12FCC13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000234928), received between Oct 7, 2024 and Dec 18, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABILIZED IN THE ELECTROPHYSIOLOGY LAB BEFORE BEING TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY WITH THE DRAIN IN PLACE. THE PATIENT REQUIRED UNEXPECTED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 23839790 ↗
• MalfunctionDec 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREP FOR A CARDIAC ABLATION PROCEDURE, THE SHEATH SIDE PORT TUBING OF THE HAD A WHITE COATING ON THE OUTSIDE, WHICH WAS CLEARLY VISIBLE WHEN BLOOD WAS ASPIRATED. THE PHYSICIAN OBSERVED THAT THE COATING WAS ONLY PRESENT ON THE OUTSIDE AND DETERMINED THAT IT DID NOT AFFECT THE INTEGRITY OF THE INSIDE TUBING. THE PROCEDURE WAS COMPLETED WITH THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776035 ↗
• MalfunctionFeb 13, 2025Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE INVOLVING A BALLOON CATHETER AND A SHEATH, SEVERAL ISSUES WERE IDENTIFIED. THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM, AND THE DEFLECTION MECHANISM OF THE SHEATH BROKE, LEADING TO A LOSS OF STEERABILITY. THE DOCTOR HEARD A SNAPPING SOUND DURING DEFLECTION, AFTER WHICH THE SHEATH COULD NO LONGER DEFLECT. TO ADDRESS THESE ISSUES, THE BALLOON CATHETER AND THE SHEATH WERE BOTH REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING CRYOABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378814 ↗
• MalfunctionFeb 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE INTEGRATED DILATOR/NEEDLE WOULD NOT LOCK INTO THE SHEATH. THE NATIVE DILATOR LOCKED INTO THE SHEATH. THE INTEGRATED DILATOR/NEEDLE WAS REPLACED AND THE ISSUE REMAINED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355680 ↗
• MalfunctionDec 11, 2024Fluid/Blood Leak; Gas/Air Leak; Material Twisted/Bent; Fluid/Blood Leak; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SHEATH, AIR BUBBLES REPEATEDLY FORMED IN THE SHEATH, MAKING IT DIFFICULT TO ASPIRATE AFTER THE BALLOON WAS INSERTED. THE PHYSICIAN EXPRESSED DISCOMFORT IN PROCEEDING DUE TO THE PRESENCE OF AIR BUBBLES. THE SHEATH WAS REPLACED WITH ANOTHER MODEL SHEATH, WHICH RESOLVED THE ISSUE, ALLOWING THE PROCEDURE TO BE COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901345 ↗
• InjuryOct 7, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TRANSSEPTAL ACCESS WAS DIFFICULT TO OBTAIN WITH THE SHEATH. FOLLOWING THE LAST ABLATION, AN EFFUSION AROUND THE VENTRICLE WAS OBSERVED. PERICARDIOCENTESIS WAS SUBSEQUENTLY PERFORMED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 20392115 ↗