Arctic Front Advance ProRecalls & reported problems across all models

We found 8 models of Arctic Front Advance Pro by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 375 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2019 and Dec 9, 2025 — classified as 9 deaths, 147 injuries, 219 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (111 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Arctic Front Advance Pro problems

Arctic Front Advance Pro models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  3 deaths104 reports
• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 deaths97 reports
• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  4 deaths97 reports
• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  38 reports
• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  32 reports
• Arctic Front Advance Pro™ AFAPRO28

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  4 reports
• Arctic Front Advance Pro™ AFAPRO23

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports
• Arctic Front Advance Pro™ AFAPRO23

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 report

Recent Arctic Front Advance Pro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABILIZED IN THE ELECTROPHYSIOLOGY LAB BEFORE BEING TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY WITH THE DRAIN IN PLACE. THE PATIENT REQUIRED UNEXPECTED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 23761210 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE LEFT SIDED VEINS WERE ISOLATED AND, WHILE CRYOABLATION THERAPY WAS ADMINISTERED ON THE RIGHT SIDED VEINS, LOSS OF DIAPHRAGM STIMULATION FOR THE PHRENIC NERVE OCCURRED. THE PHYSICIAN REQUESTED THAT THERAPY BE STOPPED, AND CRYOTHERAPY WAS IMMEDIATELY DISCONTINUED. PHRENIC NERVE INJURY WAS IDENTIFIED, AND PHRENIC NERVE ACTIVITY HAD NOT RETURNED AT THE CONCLUSION OF THE CASE. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 23737982 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED PAROXYSMAL EPISODES OF ATRIAL FIBRILLATION WITH A REPORTED BURDEN RANGING FROM 25-70%, INCREASED DYSPNEA ON EXERTION PARTICULARLY WITH STAIR CLIMBING AND LIGHTHEADEDNESS WITH STAIR CL IMBING. ELECTROCARDIOGRAM TESTING WAS PERFORMED THAT  RESULTED IN A CLINICALLY SIGNIFICANT DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER, AND AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED THAT IDENTIFIED CAVOTRICUSPID ISTHMUS (CTI) LINE INDUCIBLE TYPICAL ATRIAL FLUTTER. A REPEAT ABLATION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter

  MAUDE report 23538269 ↗
• 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 ↗
• MalfunctionOct 9, 2025Excessive Cooling; Protective Measures Problem; Excessive Cooling; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE OF THE BALLOON QUICKLY DROPPED TO -60 DEGREES IN THE MIDDLE OF THE THERAPY DELIVERY. THE CONSOLE WAS 'DOUBLE-STOPPED' TO CONCLUDE THERAPY DELIVERY AND INDUCE BALLOON DEFLATION. A SECOND INFLATION WAS COMPLETED AND UPON INITIAL THERAPY DELIVERY, THE TEMPERATURE OF THE BALLOON QUICKLY DROPPED BELOW -60 DEGREES. THE BALLOON CATHETER WAS DOUBLE-STOPPED TO END THERAPY AND DEFLATE THE BALLOON. THIS PROCESS HAPPENED THREE TOTAL TIMES. AFTER THE THIRD DEFLATION, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. TEMPERATURE OF THE BALLOON RAPIDLY DROPPED TO BELOW -60 DEGREES DURING THERAPY DELIVERY. MULTIPLE THERAPY INTERRUPTIONS OCCURRED, REQUIRING "DOUBLE-STOP" INTERVENTION AND BALLOON DEFLATION. THIS PROCESS WAS REPEATED THREE TIMES. AFTER THE THIRD DEFLATION, A RED SYSTEM NOTICE APPEARED ON THE CONSOLE. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE 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 23253772 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED ACUTE HYPOXIA RESPIRATORY FAILURE. IT WAS ADDITIONALLY RE PORTED THAT THE PATIENT EXPERIENCED CHEST DISCOMFORT AND SHORTNESS OF BREATH. COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND NO ABNORMALITIES WERE SHOWN. IT WAS NOTED THAT THE PATIENT HAD MILD FLUID OVERLOAD AND HAD A TRACE OF PERICARDIAL EFFUSION ON THE TRANSTHORACIC ECHOCARDIOGRAM (TTE). MEDICATION WAS ADMINISTERED FOR THE PATIENT'S PERICARDITIS. PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Dyspnea; Hypoxia; Pericardial Effusion; Pericarditis

  MAUDE report 23037132 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE USING THE CATHETER AFAPRO23 AFA PRO 23, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION AFTER THE FIRST CRYO ABLATION IN THE LEFT INFERIOR PULMONARY VEIN. FREEZE PARAMETERS WERE NORMAL AT -63 DEGREES FOR 180 SECONDS, AND THE ONSET OF ST SEGMENT ELEVATION OCCURRED 2 MINUTES AND 45 SECONDS INTO THE FREEZE. INTERVENTIONAL CARDIOLOGY WAS CONTACTED, AND 10MG INTRAVENOUS VASODILATOR MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. CORONARY ANGIOGRAPHY REVEALED COMPLETED OCCLUSION OF THE RIGHT CORONARY ARTERY AND CHRONIC CORONARY ARTERY DISEASE IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. THE PATIENT EXHIBITED SMALL RUNS OF VENTRICULAR TACHYCARDIA AND PREMATURE VENTRICULAR CONTRACTIONS, WHICH WERE TREATED WITH 150MG OF AN ANTIARRHYTHMIC MEDICATION. AN INTERVENTIONALIST INJECTED 300MCG INTRACORONARY VASODILATOR MEDICATION INTO THE AORTIC ROOT/RIGHT CORONARY ARTERY, WHICH IMMEDIATELY RESOLVED THE ST SEGMENT ELEVATION. THE EVENT WAS DIAGNOSED AS ACUTE CORONARY SPASM. THE PATIENT WAS STABLE, TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MEDICAL MANAGEMENT, AND UNDERWENT A COMPUTED TOMOGRAPHY SURG

  Patient problems: Cramp(s) /Muscle Spasm(s); Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 22772114 ↗
• MalfunctionJul 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS LATER REPORTED THAT BOTH THE STERILE BARRIER AND THE PACKAGING BOX WERE UNDAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522955 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, DURING ABLATION OF THE RIGHT INFERIOR PULMONARY VEIN, PHRENIC NERVE PALSY OCCURRED. THE PROCEDURE WAS ABORTED AND 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 22402241 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOBALLOON ABLATION PROCEDURE, PHRENIC NERVE PALSY OCCURRED WHEN THE PHYSICIAN DID NOT FEEL DIAPHRAGM PALPATION WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN, LEADING TO THE IMMEDIATE CESSATION AND ABORTION OF THE PROCEDURE. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT, AND THE EVENT DID NOT LEAD TO OR EXTEND HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 22392589 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CRYOABLATION OF THE LEFT INFERIOR PULMONARY VEIN USING THE BALLOON CATHETER, THE PATIENT DEVELOPED HEART BLOCK, WHICH PROGRESSED INTO ASYSTOLE. CRYOABLATION WAS STOPPED IMMEDIATELY. CHEST COMPRESSIONS AND OTHER RESUSCITATIVE INTERVENTIONS WERE PERFORMED. A BLOOD TRANSFUSION WAS ADMINISTERED, TEMPORARY PACING WIRES WERE PLACED, AND THE PATIENT WAS LEFT INTUBATED POST-PROCEDURE. THE CASE WAS ABORTED AND THE PATIENT REQUIRED UNEXPECTED HOSPITALIZATION, INCLUDING ADMISSION TO THE INTENSIVE CARE UNIT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Heart Block

  MAUDE report 22141015 ↗
• MalfunctionMay 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, PHYSICAL DAMAGE WAS OBSERVED AS THE BALLOON CATHETER'S TIP AND SHAFT WAS KINKED, PREVENTING THE MAPPING CATHETER FROM PASSING THROUGH. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE KINK BY PULLING BACK ON THE BLUE PULL WIRE "STRETCH" LEVER ON THE HANDLE, WHICH TEMPORARILY STRAIGHTENED THE KINK, BUT THE KINK RETURNED UPON RELEASE. 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 22113914 ↗
• MalfunctionMay 2, 2025Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WAS PHYSICAL DAMAGE TO THE BALLOON CATHETER, SPECIFICALLY THE FLUID PORT ON THE CATHETER WAS BLOCKED, PREVENTING FLUSHING THROUGH THE PORT AND THE PASSAGE OF A GUIDEWIRE. THE BALLOON CATHETER WAS REPLACED, WHICH RESOLVED THE ISSUE. 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 21949024 ↗
• MalfunctionApr 29, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WERE ISSUES WITH INSERTING THE MAPPING CATHETER INTO THE BALLOON CATHETER. POST ABLATION, THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT IN ORDER TO POST MAP AND CHECK PULMONARY VEIN ISOLATION. UPON ATTEMPTING TO REINSERT THE BALLOON CATHETER FOR FURTHER ABLATIONS, THE CATHETER BECAME DIFFICULT TO PASS THROUGH THE FLEXCATH SHEATH. A KINK WAS OBSERVED IN THE BALLOON CATHETER NEAR THE DISTAL END. THE BALLOON CATHETER WAS RE-PREPPED BUT THEN THE MAPPING CATHETER WOULD NOT ADVANCE TO THE END OF THE BALLOON. A KINK WAS ALSO NOTED IN THE MAPPING CATHETER WHEN REMOVED. BOTH THE BALLOON AND MAPPING CATHETERS WERE 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 21930099 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AT THREE MONTH FOLLOW UP, POST A CARDIAC ABLATION PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTY SWALLOWING, DISCOMFORT, BELCHING AND FOOD BEING STUCK. A VAGAL NERVE INJURY WAS SUSPECTED AS POSTOPERATIVE COMPLICATION FROM THE ABLATION PROCEDURE. THE SYMPTOMS PERSISTED AT THE SIX-MONTH FOLLOW-UP. AN UPPER GASTROINTESTINAL ENDOSCOPY. THE OUTCOME OF THIS COMPLICATION WAS REPORTED AS RECOVERING/RESOLVING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dysphagia/ Odynophagia; Nerve Damage

  MAUDE report 21918458 ↗

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