FlexCath Contour™ 10FCC20Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000659097), received between Mar 7, 2024 and Nov 7, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT EXTENDED HOSPITALIZATION AFTER THE PROCEDURE.

  Patient problems: Hematoma; Non specific EKG/ECG Changes; Pericarditis

  MAUDE report 23498445 ↗
• MalfunctionMar 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, WHEN ATTEMPTING TO DEFLECT INTO THE LEFT INFERIOR PULMONARY VEIN (LIPV), AN AUDIBLE SOUND WAS HEARD THAT WAS SURMISED TO BE A PULL WIRE SNAPPING IN THE SHEATH. AFTER THAT, THE SHEATH WAS UNABLE TO DEFLECT. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731842 ↗
• MalfunctionJan 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE PULSE FIELD ABLATION SYSTEM, THERE WAS AN ISSUE WITH THE SHEATH SIDE PORT TUBING, WHICH KINKED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057630 ↗
• MalfunctionDec 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE PULSE FIELD ABLATION SYSTEM, A KINK WAS OBSERVED AT THE SIDE PORT OF THE SHEATH. THE HEALTHCARE PROFESSIONAL EXPRESSED CONCERN THAT THE KINK COULD POTENTIALLY LEAD TO COMPLICATIONS; HOWEVER, THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT SYMPTOMS OR COMPLICATIONS. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860510 ↗
• MalfunctionDec 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE PULSE FIELD ABLATION SYSTEM, THE SIDE PORT OF THE SHEATH TUBING KINKED. THE PROCEDURE WAS COMPLETED WITH PFA.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845201 ↗
• MalfunctionOct 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE SIDE PORT TUBING ON THE SHEATH HANDLE KINKED. IT WAS SURMISED VIA CUSTOMER FEEDBACK THAT THIS MALFUNCTION COULD LEAD TO CLOTTING IN THE DEVICE HANDLE. DESPITE THE ISSUE, THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561102 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT'S HEART RATE WAS HIGHER THAN EXPECTED. IMAGING WAS CARRIED OUT AND A PERICARDIAL EFFUSION WAS OBSERVED. A PERICARDIAL TAP WAS THEN CARRIED OUT ON THE PATIENT. THE CASE WAS COMPLETED WITH CRYO. THE PATIENTS HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion; Tachycardia

  MAUDE report 19943319 ↗
• MalfunctionMay 20, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN RADIOFREQUENCY (RF) PROCEDURE, THE SIDEARM WAS KINKED. IT WAS FURTHER REPORTED THAT AIR BUBBLES WERE OBSERVED BY THE PHYSICIAN. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351041 ↗
• MalfunctionMay 13, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE, AFTER THE CATHETER WAS REPLACED, THE FLUSH LINE OF THE SHEATH COULD NOT BE ASPIRATED. IT WAS NOTED THAT THE SIDEARM WAS KINKED. THE SIDEARM WAS UNKINKED TO RESOLVE THE ISSUE. IT WAS ALSO REPORTED THAT MICROBUBBLES WERE SEEN DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION (PFA). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305514 ↗
• MalfunctionApr 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE INTEGRATED DILATOR/NEEDLE WOULD NOT LOCK FIRMLY INTO THE SHEATH DESPITE MULTIPLE ATTEMPTS. IT WAS ALSO REPORTED THAT LARGE BUBBLES WERE OBSERVED IN THE SIDE PORT OF THE SHEATH. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054409 ↗
• MalfunctionApr 2, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION, AIR BUBBLES WERE NOTED IN SIDE ARM DURING CATHETER REMOVAL AND INSERTION AND BUBBLES SEEN DURING ASPIRATION OF SIDE ARM WITH CATHETER IN THE SHEATH. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017683 ↗
• MalfunctionMar 29, 2024Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE VALVE ON THE SHEATH WAS LEAKY. THE VALVE CONTINUED TO LEAK WHEN THE CATHETER WAS REMOVED FROM THE SHEATH. DESPITE THE ISSUE, THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005452 ↗
• MalfunctionMar 25, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE SIDE PORT OF THE SHEATH HAD A KINK AND MICROBUBBLES WERE OBSERVED IN THE SIDE PORT. DESPITE THE ISSUES, CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967006 ↗
• MalfunctionMar 19, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE SIDE PORT OF THE SHEATH HAD A KINK IN IT. THE SIDEARM OF THE SHEATH WAS AGAINST THE PATIENT, AND WHILE ASPIRATION WAS BEING PERFORMED, MICROBUBBLES WERE OBSERVED IN THE SIDEARM. DESPITE THE ISSUES, CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935311 ↗
• MalfunctionMar 7, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, MICROBUBBLES WERE OBSERVED IN THE SIDEARM OF THE SHEATH. THE BUBBLES SEEMED TO BE MORE PRONOUNCED DURING ASPIRATION OF THE SHEATH UPON CATHETER REMOVAL. DESPITE THE ISSUE, THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861744 ↗