Arctic Front Advance Pro™ AFAPRO28 (UDI 00763000341503)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00763000341503), received between Dec 28, 2021 and Nov 10, 2025 — classified as 4 deaths, 36 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (37 reports).

1 other recall cover devices cleared under the same FDA submission (P100010); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 5 MONTHS FOLLOWING A CARDIAC ABLATION PROCEDURE, THE PATIENT HAD A RECURRENCE OF ATRIAL FIBRILLATION RESULTING IN A REPEAT ABLATION PROCEDURE. THE PATIENT RECOVERED AND THE OUTCOME WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23513146 ↗
• MalfunctionNov 4, 2024Use of Device Problem; Excessive Cooling; Use of Device Problem; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE COLDER THAN EXPECTED VERY EARLY IN THE ABLATION AND THEY WERE UNABLE TO FULLY OCCLUDE AS A RESULT. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE AUTO CONNECTION BOX WAS THEN BYPASSED WITHOUT RESOLVE. THE BALLOON CATHETER 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 20600337 ↗
• MalfunctionOct 14, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A FAST TEMPERATURE DROP OCCURRED. IT WAS NOTED THAT THE BALLOON CATHETER WAS NOT TOO DEEP IN THE VEIN. ADDITIONALLY, IT WAS STATED THAT THE AUTO CONNECTION BOX WAS BROKEN. THE AUTO CONNECTION BOX WAS REPLACED. 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 20441402 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, A CHEST X-RAY SHOWED PLEURAL EFFUSIONS WITH PULMONARY VENOUS CONGESTION. TEN MONTHS LATER THE PATIENT ARRIVED TO THE HOSPITAL WITH ABDOMINAL PAIN AND NAUSEA. THE PATIENT ALSO REPORTED DIFFICULTY SLEEPING. A BLOOD TEST SHOWED THE PATIENT'S BRAIN NATRIURETIC PEPTIDE (BNP) AND TROPONIN LEVELS WERE ELEVATED. A CHEST X-RAY WAS PERFORMED AND SHOWED BILATERAL PLEURAL EFFUSIONS AGAIN WITH PULMONARY VEIN CONGESTION AS WELL AS CARDIOMEGALY. AN ABDOMEN AND PELVIS COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE PERFORMED AND SHOWED NO ACUTE PROCESS BUT DIVERTICULOSIS AND BILATERAL PLEURAL EFFUSIONS WITH INFILTRATIVE OPACITIES IN THE LUNG. A LOOP DIURETIC WAS ADMINISTERED INTRAVENOUSLY. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED A MILDLY REDUCED LEFT VENTRICLE EJECTION FRACTION AND INDETERMINANT DIASTOLIC DYSFUNCTION. AN ELECTROCARDIOGRAM WAS PERFORMED AND SHOWED ABNORMAL RESULTS. ANOTHER BLOOD TEST WAS PERFORMED AND SHOWED SLIGHTLY ALKALINE POTENTIAL OF HYDROGEN LEVELS AND A LOW RED BLOOD CELL COUNT. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. A POTASSIUM SUPPLEMENT WAS ADMINISTERED ORALLY AND THE PATIENT'S HOME LOOP DIURETIC DOSE WA

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea; Pleural Effusion; Pulmonary Edema; Sleep Dysfunction; Tachycardia

  MAUDE report 19089011 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, THE PATIENT HAD A RECURRENCE OF ATRIAL FIBRILLATION AS IDENTIFIED ON ANOTHER MANUFACTURER'S ELECTROCARDIOGRAM (ECG) MONITOR. THE PATIENT EXPERIENCED SIMILAR SYMPTOMS "AS BEFORE." AN ANTIARRHYTHMIC WAS ADMINISTERED AND PRESCRIBED TO THE PATIENT, AND THE PATIENT WAS CARDIOVERTED BACK INTO SINUS RHYTHM. THE ADVERSE EVENT RESOLVED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 18836142 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH CRYO. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Atrial Fibrillation

  MAUDE report 18657377 ↗
• MalfunctionNov 28, 2023Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WOULD NOT ADVANCE INTO THE BALLOON CATHETER. THE BALLOON CATHETER 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 18221223 ↗
• MalfunctionNov 21, 2023Compatibility Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Compatibility Problem; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE ON THE LAST ABLATION, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. IT WAS NOTED THERE WERE ISSUES RETRACTING THE CATHETER THROUGH THE MAPPING CATHETER. AFTER THE CATHETER AND MAPPING CATHETER WERE REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE MAPPING CATHETER HAD MULTIPLE KINKS. BOTH THE CATHETER AND MAPPING CATHETER WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. THE DATA FILE WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE. THE CONSOLE APPEARED TO BE CONTROLLING PRESSURE AND FLOW IN THE EXPECTED RANGES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182236 ↗
• MalfunctionNov 17, 2023Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR WAS SEEN IN THE MANIFOLD FLUSH LINE. THE COPILOT CONNECTOR WAS REPLACED AND THE LINE WAS FLUSHED, BUT THE ISSUE PERSISTED. IT WAS THEN REPORTED THAT A CRACK WAS IN THE FLUSH LINE CONNECTOR OF THE BALLOON CATHETER. THE BALLOON CATHETER 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 18158980 ↗
• MalfunctionOct 16, 2023Device Contamination with Body Fluid; Protective Measures Problem; Device Contamination with Body Fluid; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. ANOTHER SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLUTION. THE CASE WAS SWITCHED TO RADIOFREQUENCY (RF) ABLATION. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. TEST INJECTIONS WERE PERFORMED WITHOUT ISSUES. IMAGES SHOWED BLOOD IN THE COAXIAL PORT. THE CONSOLE WAS DEINSTALLED AND DECOMMISSIONED DUE TO THE BLOOD PRESENCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940364 ↗
• DeathOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023: IT WAS LATER REPORTED THAT THE PATIENT'S HERNIA WAS CONFIRMED TO BE A PRE-EXISTING CONDITION.

  Patient problems: Abdominal Pain; Bowel Perforation; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Ischemia

  MAUDE report 17921037 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, PHRENIC CAPTURE WAS LOST. A SHORT PAUSE OCCURRED TO SEE IF IT WOULD RECOVER, BUT IT DID NOT. THERE WAS NO SIGNAL IN THE RIGHT INFERIOR PULMONARY VEIN (RIPV).  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: Nerve Damage

  MAUDE report 17862414 ↗
• InjurySep 20, 2023Adverse 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 EXPERIENCED A PERICARDIAL EFFUSION. IT WAS FURTHER REPORTED THAT THE EFFUSION OCCURRED FOLLOWING ABLATION OF THE LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT ATRIAL APPENDAGE, AND RIGHT SUPERIOR PULMONARY VEIN (RSPV). IT WAS NOTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE, AND THE PHYSICIAN VISUALIZED A SIGNIFICANT EFFUSION USING AN INTRACARDIAC ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS QUICKLY PERFORMED AND 1100 ML OF BLOOD WAS REMOVED. THE PATIENT LEFT THE LAB IN STABLE CONDITION AND WAS MONITORED FOR FURTHER DRAINAGE FROM THE PERICARDIUM. THE PATIENT WAS IN THE HOSPITAL FOR TWO DAYS FOLLOWING THE EVENT AND WAS DISCHARGED HOME WITHOUT ANY FURTHER INTERVENTION OR ISSUE. 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; Pericardial Effusion

  MAUDE report 17783390 ↗
• InjurySep 1, 2023Adverse 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 PHRENIC NERVE WAS INJURED AND PHRENIC CAPTURE WAS LOST. THE PHRENIC NERVE INJURY (PNI) WAS TRANSIENT. THE OUTCOME OF THIS CASE IS UNKNOWN. IT WAS ALSO REPORTED THAT THE DAY FOLLOWING THE CRYO ABLATION PROCEDURE, THE PATIENT HAD AN ESOPHAGEAL FISTULA AND WAS SUBSEQUENTLY ADMITTED TO THE EMERGENCY DEPARTMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fistula; Nerve Damage

  MAUDE report 17671616 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, THE PATIENT HAD POST OPERATIVE BLEEDING. THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING. THE PATIENT MAINTAINED NORMAL SINUS RHYTHM (NSR) AND WAS DISCHARGED IN STABLE CONDITION. AFTER DISCHARGE, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) FOR EVALUATION AS THE PATIENT REPORTEDLY FELL THREE TIMES AND AS A RESULT REPORTED A HEAD INJURY AND RIB PAIN. AN X-RAY WAS CARRIED OUT ON THE PATIENT AND NO MAJOR INJURIES WERE NOTED. THE PATIENT WAS FOUND TO BE ANEMIC WHICH REQUIRED TRANSFUSIONS AND HAD GUAIAC-POSITIVE STOOLS. IT WAS ALSO REPORTED THE PATIENT REPORTED INTERMITTENT HEMATOCHEZIA FOLLOWING A COLONOSCOPY APPROXIMATELY TWO WEEKS PRIOR TO THE CRYO ABLATION PROCEDURE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17640670 ↗
• MalfunctionAug 16, 2023Mechanical Problem; Device Contamination with Body Fluid; Protective Measures Problem; Mechanical Problem; Device Contamination with Body Fluid; Protective Measures Problem

  IT WAS LATER REPORTED THAT THE CASE WAS SWITCHED TO AND COMPLETED WITH RADIOFREQUENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556180 ↗
• MalfunctionAug 16, 2023Mechanical Problem; Device Contamination with Body Fluid; Protective Measures Problem; Mechanical Problem; Device Contamination with Body Fluid; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BOTH BALLOON CATHETERS HAD A BREACH AND BLOOD WAS SUCTIONED BACK INTO THE COAXIAL UMBILICAL CABLE. 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 17556062 ↗
• MalfunctionAug 15, 2023Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE BALLOON CATHETER 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 17549155 ↗
• MalfunctionAug 15, 2023Mechanical Problem; Material Twisted/Bent; Insufficient Device Problem Information; Device Handling Problem; Mechanical Problem; Material Twisted/Bent; Insufficient Device Problem Information; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE AND BEFORE THE BALLOON CATHETER ENTERED THE PATIENT, THE PULL WIRE INSIDE THE BALLOON WAS BENT AND AS A RESULT, THE BALLOON WAS NOT STRAIGHT. WHEN THE PULL WIRE AND THE TOGGLE ON THE BALLOON CATHETER HANDLE WERE MOVED, NOTHING HAPPENED TO THE BALLOON. THE BALLOON CATHETER 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 17548950 ↗
• MalfunctionAug 15, 2023Use of Device Problem; Material Deformation; Material Twisted/Bent; Use of Device Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE BALLOON CATHETER DEVELOPED A KINK WHILE NAVIGATING THE PATIENTS TORTUOUS ANATOMY. THE BALLOON CATHETER 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 17548514 ↗
• InjuryAug 11, 2023Adverse 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 "POTENTIAL" CLOT WAS OBSERVED IN THE LEFT ATRIUM VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT WAS NOT PRESENT PRIOR TO TRANSEPTAL ACCESS AND THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE CLOT. THE FIRST ABLATION WAS PERFORMED, AND THEN THE BALLOON CATHETER,  MAPPING CATHETER, AND SHEATH WERE REMOVED. THE BALLOON CATHETER AND SHEATH WERE FLUSHED AND ASPIRATED. THERE WAS NO SIGN OF A CLOT ON ANY OF THE PRODUCTS. THE ACTIVATED CLOTTING TIME WAS GREATER THAN FOUR HUNDRED SECONDS. ICE WAS UTILIZED AGAIN AND NO CLOT WAS OBSERVED. DESPITE THE CONCERNS, THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17512139 ↗
• MalfunctionAug 3, 2023Compatibility Problem; Material Integrity Problem; Protective Measures Problem; Compatibility Problem; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. THE COAXIAL UMBILICAL CABLE WAS CHECKED FOR BLOOD AND THE CABLE WAS CLEAR. THE SYSTEM NOTICE APPEARED AGAIN AND BLOOD WAS OBSERVED IN THE COAXIAL UMBILICAL CABLE. THE COAXIAL CABLE WAS DISCONNECTED AND THE BALLOON CATHETER WAS ATTEMPTED TO BE REMOVED BUT INITIALLY IT WOULD NOT COLLAPSE ENOUGH TO RETRACT BACK INTO THE SHEATH. THE BALLOON CATHETER WAS ABLE TO BE RETRACTED AND THE BALLOON CATHETER WAS REMOVED. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE REPLACED TO RESOLVE THE ISSUES. BLOOD WAS ALSO OBSERVED IN THE COAXIAL PORT AND BLOOD BOTTLE OF THE CONSOLE. THE CASE WAS COMPLETED WITH CRYO. THE CONSOLE PLANS TO BE DEINSTALLED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455982 ↗
• MalfunctionJul 21, 2023Leak/Splash; Infusion or Flow Problem; Material Integrity Problem; Leak/Splash; Infusion or Flow Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE INTRODUCER WAS PULLED OFF THE BALLOON TOO FAR. THE BLUE PUSH BUTTON ON THE HANDLE HAD TO BE USED TO GET THE BALLOON BACK INTO THE INTRODUCER. AFTER THE SHEATH AND BALLOON CATHETER WERE PREPPED AND INSERTED INTO THE BODY, THE PUMP THAT WAS ATTACHED TO THE SHEATH GAVE A 'PRESSURE' ALARM. THE SHEATH WAS SWITCHED TO A DIFFERENT PUMP, THE BALLOON CATHETER WAS REMOVED, RE-PREPPED, AND REINSERTED. AFTER THE BALLOON CATHETER WAS REINSERTED, THE NEW PUMP AND THE SHEATH DISPLAYED MICROBUBBLES. THE TUBING WAS REPLACED AND THE SALINE BAG WAS HEPARINIZED WITHOUT RESOLUTION. THE SHEATH WAS REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17371393 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, IT WAS DIFFICULT TO WAKE THE PATIENT FROM GENERAL ANESTHESIA. THE PATIENT DISPLAYED SIGNS OF A STROKE, INCLUDING NEUROLOGICAL DEFICITS. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. THE NEUROLOGICAL DEFICITS WERE NOTED TO HAVE DECREASED IN SEVERITY, BUT THE PATIENT REMAINED HOSPITALIZED AND HAS NOT YET FULLY RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 17364899 ↗
• MalfunctionJul 12, 2023Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN ATTEMPTING TO ABLATE THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE 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 17309573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100010. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2012 · Aug 29, 2011 · Terminated
  Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtr