FlexCath Advance™ 4FC12 (UDI 00763000043773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00763000043773), received between Jun 6, 2018 and Dec 14, 2020 — classified as 4 deaths, 25 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (18 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2020Device Contamination with Body Fluid; Gas/Air Leak; Device Contamination with Body Fluid; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN ASPIRATING THE SHEATH, AIR KEPT DRAWING BACK THROUGH THE VALVE. THE PHYSICIAN PUT THEIR THUMB OVER THE VALVE AND AIR STOPPED FLOWING THROUGH AND BLOOD CAME BACK INSTEAD. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. 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 11004185 ↗
• MalfunctionMar 25, 2020Device Contamination with Body Fluid; Gas/Air Leak; Material Integrity Problem; Device Contamination with Body Fluid; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS INTRODUCED INTO THE SHEATH, AIR INGRESS OCCURRED DURING ASPIRATION. A HEMOSTATIC VALVE ISSUE WAS SUSPECTED AND THE SHEATH WAS REPLACED. A LARGE AMOUNT OF BLOOD WAS NOTED ON THE SHEATH. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9880484 ↗
• DeathMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL CRYO ABLATION PROCEDURE, PERICARDIAL EFFUSION WAS EVIDENT THROUGH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. MEASURES WERE TAKEN TO OPTIMIZE BLOOD PRESSURE AND HEART RATE. PERICARDIOCENTESIS, OPEN CHEST PROCEDURE, CARDIOPULMONARY RESUSCITATION (CPR), AND BLOOD TRANSFUSIONS WERE PERFORMED. THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade; Death; Pericardial Effusion

  MAUDE report 9879087 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVE TO A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED "PERICARDIAL PAIN". THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 9819546 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT HAD CHEST PAIN AND WAS DIAGNOSED WITH PER ICARDITIS AND PNEUMONIA. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THEIR HOSPITAL STAY WAS EXTENDED. THE PATIENT IS A PARTICIPANT IN THE COMPARISON OF RF AND CRYOBALLOON ABLATION THERAPY OF AF CLINICAL STUDY NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inflammation

  MAUDE report 9176904 ↗
• InjurySep 3, 2019Adverse 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 PATIENTS VITALS SIGNS DECREASED AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. A CARDIAC TAMPONADE WAS NOTED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REQUIRED SURGICAL INTERVENTION TO REPAIR A TEAR TO THE PULMONARY VEIN RESULTING IN AN EXTENDED HOSPITAL STAY AND PATIENT REMAINS IN THE HOSPITAL ON VENTILATION SUPPORT WITH STEADY IMPROVEMENTS. THE CASE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 8956234 ↗
• MalfunctionAug 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947031 ↗
• InjuryAug 28, 2019Adverse 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 ANOTHER MANUFACTURER'S TRANSEPTAL SHEATH WENT ACROSS THE SEPTUM, AN ACUTE DROP IN PATIENT'S BLOOD PRESSURE WAS OBSERVED. THE BLOOD PRESSURE RESOLVED WITHOUT INTERVENTION. THE PATIENT WAS EVALUATED FOR A CARDIAC EFFUSION AND WHEN NO EFFUSION WAS NOTED, THE CASE WAS CONTINUED AND COMPLETED WITH CRYO. POST-OPERATIVELY, AFTER COMPANY PRODUCTS WERE REMOVED, THE PATIENT DEVELOPED CHEST PAIN AND AN EFFUSION WAS NOTED. A PERICARDIAL WINDOW WAS PERFORMED TO DRAIN THE CARDIAC TAMPONADE AND THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8941854 ↗
• MalfunctionAug 20, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS OCCURRED WHEN THE BALLOON CATHETER WAS REMOVED FROM THE SHEATH. THE SHEATH WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8912721 ↗
• MalfunctionAug 19, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, AIR INGRESS WAS OBSERVED WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH. IT WAS NOTED THE VALVE MAY NOT HAVE BEEN FUNCTIONING PROPERLY. THE SHEATH WAS REPLACED, AND THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED A THIRD TIME WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907945 ↗
• MalfunctionAug 19, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, AIR INGRESS WAS OBSERVED WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH. IT WAS NOTED THE VALVE MAY NOT HAVE BEEN FUNCTIONING PROPERLY. THE SHEATH WAS REPLACED, AND THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED A THIRD TIME WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907771 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A SUCCESSFUL CRYO ABLATION PROCEDURE, BLEEDING WAS NOTED TO THE RIGHT GROIN. THE BLEEDING WAS CONTROLLED WITH A PRESSURE DRESSING, AND ANTICOAGULANT MEDICATION WAS WITHHELD AS A RESULT OF THE BLEEDING. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION; THE PATIENT'S HEMOGLOBIN, RED BLOOD CELL COUNT AND HEMATOCRIT WERE DECREASED AS COMPARED TO PRE-PROCEDURE LEVELS. THE PATIENT WAS DISCHARGED AS HEMODYNAMICALLY STABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; Vascular System (Circulation), Impaired

  MAUDE report 8898835 ↗
• MalfunctionAug 5, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS OCCURRED WITH THE SHEATH. THE CASE WAS SWITCHED AND COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860597 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, PRIOR TO THE START OF THE PROCEDURE, AN EFFUSION WAS OBSERVED VIA INTRA CARDIAC ECHOCARDIOGRAPHY. THE PHYSICIAN CONTINUED THE CASE AND WAS ABLE TO COMPLETE WITH CRYO. FOLLOWING THE CASE, THE EFFUSION WAS INDICATED TO BE LARGER. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 8818105 ↗
• InjuryJul 22, 2019Adverse 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 ENTERED INTO THE PATIENT, A PIECE OF TISSUE WAS SEEN ON THE CARDIAC ULTRASOUND FLOATING IN THE LEFT ATRIUM. ANOTHER CATHETER WAS USED TO SUCTION AND REMOVE THE FLOATING TISSUE. 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: Tissue Damage

  MAUDE report 8813752 ↗
• MalfunctionJul 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS UNABLE TO CROSS THE SEPTUM. THE SHEATH WAS REMOVED AND DISPLAYED A KINK BETWEEN THE TIP AND THE DILATOR. THE SHEATH WAS REPLACED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770870 ↗
• MalfunctionJul 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8765200 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE TEMPERATURE WAS NOT AS EXPECTED. THE PATIENT THEN BECAME IRRITATED AND ATTEMPTED TO GET OFF OF THE TABLE. IT WAS THEN REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. AN ECHOCARDIOGRAM WAS PERFORMED IDENTIFYING AN EFFUSION THAT DEVELOPED INTO TWO TAMPONADES, WHICH WERE DRAINED PRIOR TO THE PATIENT BEING SENT TO CARDIAC SURGERY. IT WAS NOTED THAT THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA) AND THAT A BLOOD TRANSFUSION HAD TO OCCUR. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 8740521 ↗
• MalfunctionJun 17, 2019Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703694 ↗
• MalfunctionJun 11, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, AN ISSUE WITH THE HEMOSTATIC VALVE OF THE SHEATH WAS SUSPECTED. THE CASE OUTCOME WAS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8688311 ↗
• MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS BENT AND REPLACED WITH RESOLVE. ADDITIONALLY THE PHYSICIAN FELT THE SHEATH WAS LEAKING AT THE HUB AND IT WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633526 ↗
• MalfunctionMay 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS NOT ROTATING AS EXPECTED IN THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE SHEATH WAS REMOVED AND A KINK WAS OBSERVED ON THE DISTAL END OF THE SHEATH. THE SHEATH WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8597042 ↗
• MalfunctionMay 7, 2019Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS WAS NOTED WHEN ADVANCING THE BALLOON CATHETER INTO THE SHEATH. THE INTEGRITY OF THE HEMOSTATIC VALVE WAS IN QUESTION. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8586651 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, UNEXPLAINED ST SEGMENT ELEVATION WAS OBSERVED ON THE PATIENT'S ELECTROCARDIOGRAM (ECG). NO TREATMENT WAS REQUIRED. ADDITIONALLY FLUID WAS LEAKING OUT OF THE SHEATH HANDLE AND THERE WAS CONCERN THE HEMOSTATIC VALVE MIGHT BE COMPROMISED. THE SHEATH WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: ST Segment Elevation

  MAUDE report 8578457 ↗
• DeathApr 24, 2019Adverse 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 RIGHT INFERIOR PULMONARY VEIN (RIPV) WAS PERFORATED. ADDITIONALLY, THE PHYSICIAN NOTICED BLOOD IN THE ENDOTRACHEAL (ET) TUBE. BLOOD WAS SUCTIONED FROM THE ET TUBE, BUT BLEEDING CONTINUED, AND THE CASE HAD TO BE ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT IS DECEASED.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 8547205 ↗