FlexCath Advance™ 4FC12 (UDI 00643169688872)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00643169688872), received between Dec 7, 2016 and Feb 13, 2019 — classified as 4 deaths, 29 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Air Leak” (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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER THE SHEATH WAS INSERTED, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED WITH RESOLVE, AND 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 8336455 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED COUGH AND SHORTNESS OF BREATH. AN ECHO WAS PERFORMED AND SHOWED MINIMAL ANTERIOR AND POSTERIOR PERICARDIAL EFFUSION. ADDITIONALLY, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND BECAME TACHYCARDIAC. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. ECHO REVEALED THAT THE PATIENT HAD A SIGNIFICANT EFFUSION. MEDICATION WAS GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED. ULTIMATELY, THE EFFUSION RESOLVED WITH ONLY A MINIMAL EFFUSION AND THE PATIENT WAS HEMODYNAMICALLY STABLE AT DISCHARGE FROM THE LAB. THIS PATIENT WAS PART OF THE STOP AF FIRST CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 7754323 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PHYSICIAN NOTICED A SMALL PERICARDIAL EFFUSION. AS THE EFFUSION WAS GETTING LARGER, A PERICARDIOCENTESIS WAS SUBSEQUENTLY PERFORMED, AND THE PATIENT WAS TRANSFERRED TO A SURGICAL SUITE. THE CRYO CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED, AND WAS DISCHARGED TO HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 7679407 ↗
• MalfunctionJul 2, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, UPON ASPIRATION, AIR BUBBLES WERE ASPIRATED VIA THE HEMOSTATIC VALVE OF THE SHEATH. THE BALLOON CATHETER WAS ADVANCED AND RETRACTED SLIGHTLY IN AN ATTEMPT TO RESEAT THE VALVE WITHOUT RESOLVE. THE SHEATH WAS REPLACED WITHOUT RESOLVE. THE PHYSICIAN OPTED TO PLACE THE VALVE HUB OF THE SHEATH UNDER WATER, AND NO AIR BUBBLES WERE NOTED. THE CASE PROCEEDED AND 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 7654931 ↗
• MalfunctionJun 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AS A RADIOFREQUENCY CATHETER WAS INSERTED IN THE SHEATH AND TOUCH-UP WAS PERFORMED, IT WAS OBSERVED THAT BLOOD WAS LEAKING FROM THE HEMOSTATIC VALVE. AS THE BLOOD LEAKING WAS MORE THAN EXPECTED, 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 7596750 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A DROP IN BLOOD PRESSURE WAS NOTED AFTER ISOLATING THE LEFT INFERIOR PULMONARY VEIN. THE HEART WAS XRAYED WHICH SHOWED LITTLE TO NO CARDIAC MOTION. A SCAN WAS DONE WHICH REVEALED A MODERATE SIZED EFFUSION HAD DEVELOPED ON THE ANTERIOR ASPECT OF THE RIGHT VENTRICLE. A PERICARDIAL TAP WAS PERFORMED IMMEDIATELY, WHICH RESULTED IN IMPROVEMENT OF HEMODYNAMICS. THE PATIENT WAS EXTUBATED WITHOUT ISSUE AND ADMITTED TO THE HOSPITAL. THE PATIENT WAS DOING FINE SEVERAL HOURS POST PROCEDURE ACCORDING TO THE PHYSICIAN. 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: Cardiac Tamponade; Low Blood Pressure/ Hypotension; No Code Available; Pericardial Effusion

  MAUDE report 7596658 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AN ANTERIOR MODERATE PERICARDIAL EFFUSION WAS NOTICED. THE PHYSICIAN DISCONTINUED HEPARIN, REMOVED BALLOON AND SHEATH INTO THE RIGHT HEART, AND DID IMMEDIATE PERICARDIOCENTESIS. INTRACARDIAC ECHO SHOWED REMOVAL OF 550 ML OF FLUID. PROTAMINE WAS GIVEN, ABLATION WAS NOT RESUMED. THE ADVERSE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO SIGNS OF RESIDUAL EFFUSION.

  Patient problems: No Code Available; Pericardial Effusion

  MAUDE report 7593665 ↗
• MalfunctionJun 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER ISOLATION OF THE PULMONARY VEINS, AS THE BALLOON CATHETER WAS REMOVED FROM THE SHEATH, BLOOD CONTINUOUSLY FLOWED FROM THE HEMOSTATIC VALVE. 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 7574564 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHEN A COMPETITOR SHEATH WAS REPLACED WITH THE MANUFACTURER'S SHEATH, THERE WAS A DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION WAS OBSERVED BY THE ICE CATHETER. A PERICARDIAL DRAIN WAS PLACED. ALL OF THE CATHETERS WERE REMOVED FROM THE HEART. MINIMAL EFFUSION WAS EVIDENT WHEN THE PATIENT LEFT THE ROOM IN STABLE CONDITION. THE CASE OUTCOME IS UNKNOWN AND THERE IS NO FURTHER INFORMATION AVAILABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 7546378 ↗
• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INCOMING INFORMATION INDICATED THAT THE PATIENT FULLY RECOVERED.

  Patient problems: Pericardial Effusion

  MAUDE report 7522780 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED A HEMATOMA, REQUIRING A BLOOD TRANSFUSION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 7519909 ↗
• MalfunctionApr 30, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, DURING ASPIRATION, AIR INGRESS WAS OBSERVED. THE BALLOON CATHETER WAS PREPPED AND INSERTED AND AIR CONTINUED TO BE ASPIRATED. THE BALLOON CATHETER WAS MANEUVERED WITHOUT RESOLVE. THE SHEATH WAS THEN 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 7474012 ↗
• MalfunctionApr 24, 2018Kinked; Kinked

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH KINKED WHILE ACCESSING THE PATIENT'S RIGHT PULMONARY VEIN (PV). THE SHEATH WAS REPLACED WITH RESOLVE AND THE PROCEDURE 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 7454857 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. A PERICARDIAL WINDOW WAS THEN PERFORMED. THE CASE WAS COMPLETED WITH CRYO. THE PATIENT HAD AN EXTENDED HOSPITALIZATION, AND REMAINS IN THE HOSPITAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THE PATIENT WAS FEELING DELIGHTFUL THE FOLLOWING DAY.

  Patient problems: Pericardial Effusion

  MAUDE report 7409482 ↗
• InjuryMar 23, 2018Air Leak; Adverse Event Without Identified Device or Use Problem; Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX DAYS AFTER A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. PERICARDITIS WAS DIAGNOSED, AND HEART PALPITATIONS WERE ALSO OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED, AND MILD PERICARDIAL EFFUSION WAS CONFIRMED. MEDICATION WAS ADMINISTERED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT WAS PART OF THE STOP AF FIRST STUDY. INCOMING INFORMATION INDICATED THAT A PULMONARY EMBOLISM WAS OBSERVED AND THE HOSPITALIZATION STAY WAS EXTENDED.

  Patient problems: Chest Pain; Dyspnea; Inflammation; No Code Available; Pericardial Effusion; Pulmonary Embolism

  MAUDE report 7365915 ↗
• MalfunctionFeb 26, 2018Kinked; Kinked

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS KINKED AT THE DISTAL END. ADDITIONALLY, A TEAR AND LEAK WERE OBSERVED IN THE SHEATH. THE SHEATH WAS REPLACED WITH RESOLVE, AND 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 7296616 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, PERFORATION WAS OBSERVED IN THE LEFT ATRIAL APPENDAGE (LAA) WHEN CONTRAST WAS INJECTED. THE BALLOON CATHETER, SHEATH, AND MAPPING CATHETER WERE REMOVED FROM THE PATIENT. A SLIGHT DECREASE IN BLOOD PRESSURE WAS OBSERVED, AND ANTICOAGULANT WAS DISCONTINUED. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 7274341 ↗
• InjuryJan 24, 2018Adverse 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 HAD A PERICARDIAL EFFUSION. A PERICARDIAL PIGTAIL DRAIN WAS PLACED. 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 7216210 ↗
• MalfunctionJan 9, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE SHEATH PORT WAS LEAKING. THE SHEATH WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7175471 ↗
• MalfunctionJan 5, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS SLIGHT RESISTANCE WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH. AT THAT MOMENT, AIR INGRESS WAS SUSPECTED. CORONARY ARTERIOGRAPHY WAS PERFORMED, AND NO AIR WAS OBSERVED UNDER FLUOROSCOPY. THE CASE WAS COMPLETED WITH CRYO. TWO DAYS POST PROCEDURE, THERE WAS NO ISSUE WITH THE PATIENT'S STATUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7169452 ↗
• MalfunctionJan 4, 2018Air Leak; Fluid/Blood Leak; Material Integrity Problem; Air Leak; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE HEMOSTATIC VALVE OF THE SHEATH WAS DAMAGED, AND BACKFLOW OF BLOOD WAS NOTED. ADDITIONALLY, AS AIR WAS CONTINUOUSLY REMOVED THROUGH THE SIDEPORT OF THE SHEATH DURING ASPIRATION. THE SHEATH WAS THEN REPLACED WITH RESOLVE. UPON REMOVING THE SHEATH, A CRACK ON THE VALVE WAS OBSERVED. 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 7164061 ↗
• InjuryDec 21, 2017Adverse 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 HAD A PERICARDIAL EFFUSION, WHICH WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. SUBSEQUENTLY, THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR), AND OPEN CHEST THORACOTOMY. THE PATIENT WAS THEN TRANSPORTED TO THE OPERATING ROOM (OR) FOR A SUBSEQUENT PROCEDURE OR SURGERY. THE PATIENT'S HOSPITALIZATION WAS EXTENDED. THE PATIENT IS RECOVERING, AND THE EXTENT OF PERMANENT INJURIES WERE UNABLE TO BE DETERMINED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiopulmonary Arrest; Pericardial Effusion; Vascular Dissection

  MAUDE report 7139815 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CRYO ABLATION PROCEDURE AND PRIOR TO ANOTHER PROCEDURE BEING STARTED, THE PATIENT BECAME HYPOTENSIVE. A TEAR IN THE ATRIAL SEPTUM WAS EVIDENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT IS STABLE AND IS SCHEDULED FOR A SURGICAL REPAIR. THE PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 7096653 ↗
• InjuryNov 21, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, TRANSIENT ISCHEMIC ATTACK OCCURRED. IT WAS NOTED THAT AIR MAY HAVE FLUSHED INTO A SHEATH. THE PATIENT FULLY RECOVERED THE FOLLOWING DAY TO THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2017, 10:11:54: INCOMING INFORMATION INDICATED THAT THE HOSPITAL STAFF FLUSHED AIR INTO THE SHEATH WHILE ATTEMPTING TO DRAW BLOOD.

  Patient problems: Stroke/CVA

  MAUDE report 7050090 ↗
• DeathNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED MECHANICAL-ELECTRICAL DYSSYNCHRONY. THE PATIENT WAS ATTEMPTED TO BE RESUSCITATED, BUT DIED IN THE LAB.

  Patient problems: Cardiac Arrest; Death; Electro-Mechanical Dissociation

  MAUDE report 7011503 ↗