FlexCath Contour™ 12FCC20Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000234935), received between Apr 8, 2024 and Dec 16, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Gas/Air Leak; Material Deformation; Material Integrity Problem; Device Handling Problem; Gas/Air Leak; Material Deformation; Material Integrity Problem; Device Handling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SHEATH 12FCC20 FLEXCATH CONTOUR 12F, PHYSICAL DAMAGE OCCURRED TO THE SHEATH HANDLE, WHICH SPLIT AT THE SEAM AND CAUSED THE WHITE PIECES TO SEPARATE, CREATING A SHARP EDGE OF PLASTIC. STEERABILITY AND MANEUVERABILITY ISSUES WERE NOTED, ALONG WITH AIR INGRESS. IT WAS SUSPECTED THAT A POTENTIAL COMPROMISE OF VALVE INTEGRITY, RISKING INGRESS OF AIR OCCURRED. THE SHEATH WAS NOT REPLACED, AND THE PROCEDURE 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 23816173 ↗
• MalfunctionApr 17, 2025Gas/Air Leak; Material Integrity Problem; Material Twisted/Bent; Gas/Air Leak; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS AIR INGRESS AND AN INABILITY TO SUCCESSFULLY REMOVE BUBBLES WHEN ASPIRATING THE SIDE PORT OF THE SHEATH. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. 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 21855222 ↗
• MalfunctionFeb 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE SHEATH DEFLECTION KNOB WAS UNABLE TO TURN CLOCKWISE. 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 21330984 ↗
• MalfunctionDec 6, 2024Gas/Air Leak; Material Integrity Problem; Material Twisted/Bent; Gas/Air Leak; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SHEATH, THERE WAS AN ISSUE OF AIR INGRESS AND HEMOSTATIC VALVE FAILURE. IT WAS NOTED THAT SCRUB TECH DID NOT WET AND WIPE THE DILATOR BEFORE INSERTION INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH PULSED FIELD ABLATION. STEPS TO PREVENT FUTURE ISSUES INCLUDED EDUCATING THE SCRUB TECH TO WET AND WIPE THE DILATOR BEFORE INSERTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860637 ↗
• InjuryNov 21, 2024Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE INVOLVING THE USE OF A SHEATH, A SEPTAL DEFECT OCCURRED FOLLOWING THE REMOVAL OF THE SHEATH. ADDITIONALLY, THE PATIENT EXPERIENCED HYPOTENSION AFTER AN ATTEMPT WAS MADE TO INSERT THE ICE CATHETER INTO THE LEFT ATRIUM ALONGSIDE THE SHEATH. THE CATHETER DID NOT PASS EASILY, LEADING TO THE SHEATH BEING PULLED BACK TO ALLOW PASSAGE. THE SHEATH'S POSITION COULD NOT BE VERIFIED ON ICE, PROMPTING IT TO BE PULLED BACK TO THE RIGHT ATRIAL LEAD AND THEN READVANCED, AFTER WHICH THE PATIENT BECAME HYPOTENSIVE. THIS REQUIRED MEDICAL INTERVENTION WITH BOLUSES AND A VASOPRESSOR DRIP. AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE DEVICE WAS SUBSEQUENTLY IMPLANTED TO ADDRESS THE SEPTAL DEFECT. THE PROCEDURE WAS COMPLETED USING CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Tissue Injury

  MAUDE report 20744926 ↗
• InjuryOct 1, 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 LATER REPORTED THAT THE INFERIOR VENA CAVA TEAR OCCURRED FROM AN EXCHANGE BETWEEN THE SHEATH AND ANOTHER MANUFACTURER'S SHEATH. IT WAS ALSO LATER REPORTED THAT THE PATIENT BECAME HYPOTENSIVE AND THE TEAR WAS CONFIRMED USING FLUOROSCOPY. A STENT AND BALLOON OCCLUSION WERE PLACED AND THE TEAR RESOLVED ON IT'S OWN.

  Patient problems: Great Vessel Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 20344783 ↗
• MalfunctionJul 23, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH SHAFT AND SIDE PORT WERE KINKED. THE HANDLE OF THE SHEATH ALSO SEPARATED. DESPITE THE ISSUES, 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 19811098 ↗
• MalfunctionJul 23, 2024Gas/Air Leak; Material Deformation; Gas/Air Leak; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER BUCKLED WHEN FORWARD PRESSURE WAS APPLIED AND THE LUER WAS BROKEN. IT WAS ALSO REPORTED THAT THE SHEATH HANDLE HAD SEPARATION NEAR THE VALVE. WHEN THE BALLOON CATHETER WAS REPLACED, MICROBUBBLES WERE OBSERVED IN THE SIDE PORT OF THE SHEATH AND THE SHEATH WAS ASPIRATED. THE CASE WAS CHANGED TO RADIOFREQUENCY (RF) AND 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 19809938 ↗
• MalfunctionJul 16, 2024Gas/Air Leak; Material Deformation; Gas/Air Leak; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS AIR INGRESS. IT WAS ALSO REPORTED THAT THE SHEATH DEFLECTION MECHANISM COVER BROKE OFF AND THE SEAM ON THE HANDLE WAS NOT COMPLETELY SEALED. DESPITE THE ISSUES, 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 19752217 ↗
• MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE AFTER PROPER SHEATH PREPARATION, AIR INGRESS FROM MICROBUBBLES IN THE SIDE PORT TUBING WHEN ASPIRATING BLOOD AFTER SHEATH INSERTION WAS OBSERVED. 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 19714053 ↗
• MalfunctionJul 9, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, MICRO BUBBLES WERE NOTED WHEN THE SHEATH WAS FLUSHED/ASPIRATED. ADDITIONALLY, THE SIDE PORT WAS KINKED WHERE IT CONNECTED TO THE SHEATH. THE SHEATH WAS FLUSHED AND ASPIRATED TO REMOVE THE MICRO BUBBLES. 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 19699891 ↗
• MalfunctionJun 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, NUMEROUS AMOUNT OF MICROBUBBLES WERE OBSERVED IN THE SIDE PORT OF THE SHEATH DURING ASPIRATION AFTER TRANSSEPTAL PUNCTURE. MULTIPLE SYRINGES WERE USED IN ATTEMPT TO CLEAR OUT THE MICROBUBBLES WITHOUT RESOLUTION. WHEN THE SHEATH WAS PUT IN A NEUTRAL POSITION WITH NO DEFLECTION AND A SMALLER SYRINGE WAS USED THE MICROBUBBLES CLEARED OUT, HOWEVER, MICROBUBBLES APPEARED AGAIN WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH AND ASPIRATION WAS PERFORMED AGAIN. WITH GREAT DIFFICULTY, MICROBUBBLES WERE EVENTUALLY ABLE TO BE CLEARED OUT AGAIN. 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 19605760 ↗
• MalfunctionJun 4, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE SHAFT OF THE SHEATH WAS KINKED WHICH SUBSEQUENTLY CAUSED AN AIR INGRESS 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 19464438 ↗
• MalfunctionMay 2, 2024Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Device Handling Problem; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE VALVE DID NOT FEEL AS SMOOTH AS ANOTHER MANUFACTURER'S SHEATH. CUSTOMER FEEDBACK WAS PROVIDED INDICATING THAT THE "BIDIRECTIONAL CURVES" WERE UNNECESSARY. IT WAS ALSO REPORTED THAT THE TRANSITION OF THE SHEATH WAS NOT "SIGNIFICANT ENOUGH" AND ANOTHER MANUFACTURER'S SHEATH HAD A "BETTER" TRANSITION. DESPITE THE ISSUES, 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 19234644 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, SMALL AIR BUBBLES WERE NOTED WHEN FLUSHING THE SHEATH ONCE THE BALLOON CATHETER WAS INSERTED. IT WAS NOTED THAT THE BALLOON CATHETER SHAFT WAS COMPLETELY STRAIGHT AND THERE WAS NO EXTRA LATERAL PRESSURE ON THE SEALING VALVE. A SMALLER SYRINGE WAS THEN USED TO FLUSH THE SHEATH AND NO MORE AIR BUBBLES WERE NOTED. 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 19151640 ↗
• MalfunctionApr 8, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, IT WAS DIFFICULT TO ASPIRATE THE SHEATH AND MICROBUBBLES WERE OBSERVED. THE SYRINGE NEEDED TO BE PULLED BACK MORE SLOWLY THAN EXPECTED TO CLEAR THE MICROBUBBLES. DESPITE THE ISSUES, 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 19060805 ↗