FlexCath Advance™ 4FC12 (UDI 00763000217136)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00763000217136), received between Aug 23, 2019 and Nov 22, 2021 — classified as 17 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (19 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2021Device Contamination with Body Fluid; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Device Contamination with Body Fluid; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS DRAWN INTO THE SHEATH VIA THE SIDEPORT AFTER INSERTING IT INTO THE PATIENT. THE BALLOON CATHETER WAS INSERTED, BUT BLOOD CONTINUED TO ENTER THE SIDEPORT OF THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED, IN WHICH AIR INGRESS OCCURRED. ST ELEVATION WAS THEN OBSERVED. A VASODILATOR WAS ADMINISTERED AND THE ST ELEVATION RESOLVED. THE CASE WAS COMPLETED WITH CRYO. FOLLOWING THE PROCEDURE, THE PATIENT DID NOT WAKE UP FROM ANESTHESIA. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND A CEREBRAL INFARCTION AND EMBOLUS WAS CONFIRMED IN THE LEFT HEMISPHERE OF THE BRAIN DUE TO AIR EMBOLISM. THE PATIENT DISPLAYED SIGNS OF PARALYSIS ON THEIR RIGHT SIDE AND HAD DIFFICULTY SPEAKING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes; Paralysis; Speech Disorder

  MAUDE report 12858701 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER THE SHEATH WAS INSERTED INTO THE PATIENT, THE PATIENT BECAME HYPOTENSIVE AND A CARDIAC TAMPONADE WAS DETECTED. THE PROCEDURE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 12301561 ↗
• MalfunctionMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  AFTER A COMPLETED CASE, THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872422 ↗
• MalfunctionMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  AFTER A COMPLETED CASE, THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871881 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, UPON THE FIRST ABLATION, THE PATIENTS ARTERIAL PRESSURE DROPPED AS WELL AS A WEAK FEMORAL PULSE OBSERVED. ST ELEVATION WAS ALSO NOTED TO OCCUR FOR SIX MINUTES. MEDICATION WAS ADMINISTERED TO THE PATIENT AND THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 11537018 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Material Twisted/Bent

  THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURERS INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11437121 ↗
• MalfunctionJan 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE SHEATH BUCKLED AND KINKED WHEN THE BALLOON CATHETER WAS ADVANCED. ANOTHER ATTEMPT WAS MADE WITHOUT SUCCESS. THE SHEATH WAS REPLACED, AND THE SAME ISSUE OCCURRED TO A LESSER DEGREE. 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 11244520 ↗
• MalfunctionJan 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYOBLATION PROCEDURE, THE SHEATH BUCKLED AND KINKED WHEN THE BALLOON CATHETER WAS ADVANCED. ANOTHER ATTEMPT WAS MADE WITHOUT SUCCESS. THE SHEATH WAS REPLACED, AND THE SAME ISSUE OCCURRED TO A LESSER DEGREE. 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 11244514 ↗
• MalfunctionJan 25, 2021Material Twisted/Bent; Material Twisted/Bent

  THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURERS INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11226061 ↗
• MalfunctionJan 25, 2021Material Twisted/Bent; Material Twisted/Bent

  THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURERS INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11225953 ↗
• MalfunctionJan 14, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR BUBBLES WERE NOTED IN TRANSSEPTAL SALINE LINE OF THE SHEATH WHEN INSERTING THE BALLOON CATHETER. THE SHEATH WAS REPLACED TO RESOLVE 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 11171753 ↗
• MalfunctionJan 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE SHEATH WAS LEAKING AT THE INTERFACE BETWEEN THE HANDLE AND SIDE PORT. THE SHEATH WAS REPLACED TO RESOLVE 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 11132710 ↗
• MalfunctionJan 7, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, THE PHYSICIAN COULD NOT PREVENT AIR FROM STOPPING WHEN ASPIRATING. A HEMOSTATIC VALVE ISSUE WAS SUSPECTED. THE SHEATH WAS REPLACED, BUT WHEN THE BALLOON CATHETER WAS INSERTED, A STREAM OF AIR BUBBLES WAS NOTED. IT WAS NOTED THE BALLOON CATHETER WAS A TIGHT FIT GOING INTO THE SHEATH. THE BALLOON CATHETER WAS REPLACED, RESOLVING 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 11132134 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Device Contamination with Body Fluid; Fluid/Blood Leak; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS PLACED INTO THE SHEATH, THE SHEATH VALVE ALLOWED 'A SIGNIFICANT AMOUNT' OF BLOOD TO PASS BY THE BALLOON CATHETER AND OUT OF THE SHEATH. THE SHEATH WAS REPLACED, RESOLVING 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 11127701 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN ABLATING THE POSTERIOR WALL, THE PATIENT DEVELOPED HEART BLOCK AND HYPOTENSION. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. CARDIOPULMONARY RESUSCITATION (CPR) WAS GIVEN. THE PATIENT WAS HOSPITALIZED, AND RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 11013186 ↗
• MalfunctionDec 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE DISTAL SHAFT OF THE SHEATH WAS KINKED AND COULD NOT BE MANIPULATED AS EXPECTED. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. 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 11004681 ↗
• MalfunctionDec 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS REMOVED AND A TWIST ON THE DISTAL END WAS OBSERVED. THE CASE WAS ALREADY 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 10962650 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, AN EFFUSION WAS CONFIRMED WITH AN INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 10926882 ↗
• MalfunctionNov 11, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHAFT OF THE SHEATH BECAME KINKED. IT WAS NOTED THAT THE BALLOON CATHETER COULD NOT BE FULLY RETRACTED OR PULLED OUT OF THE SHEATH. 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; No Consequences Or Impact To Patient

  MAUDE report 10822860 ↗
• MalfunctionNov 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH APPEARED TO BE MORE CURVED THAN NORMAL AND IT WAS SUSPECTED THAT A POSSIBLE KINK OCCURRED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817946 ↗
• MalfunctionNov 4, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR BUBBLES WERE NOTED AFTER THE BALLOON CATHETER WAS INSERTED IN THE SHEATH. THE BALLOON CATHETER WAS RE-INSERTED INTO THE SHEATH WITHOUT RESOLVING THE ISSUE. THE SHEATH WAS THEN 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 Consequences Or Impact To Patient

  MAUDE report 10786164 ↗
• InjuryOct 26, 2020Adverse 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 DEVELOPED A CARDIAC TAMPONADE WITH PERICARDIAL EFFUSION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE EFFUSION WAS DRAINED AND THE PATIENT HOSPITALIZED FOR AN EXTRA DAY FOR MONITORING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 10738545 ↗
• MalfunctionOct 6, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH KINKED. 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; No Consequences Or Impact To Patient

  MAUDE report 10636581 ↗
• MalfunctionSep 29, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BROWN STAINS WERE FOUND IN THE PACKAGING WHEN REMOVING THE SHEATH. THE SHEATH WAS REPLACED AS A PRECAUTION 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 Consequences Or Impact To Patient

  MAUDE report 10601871 ↗
• MalfunctionSep 28, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE HEMOSTATIC VALVE WAS OBSERVED TO BE BROKEN. 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 Consequences Or Impact To Patient

  MAUDE report 10597849 ↗