Arctic Front AdvanceRecalls & reported problems across all models

We found 11 models of Arctic Front Advance by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 377 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2016 and Mar 25, 2025 — classified as 11 deaths, 137 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (71 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 problems

Arctic Front Advance models

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

• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  9 deaths144 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 death75 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  58 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  37 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  25 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 death23 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  6 reports
• Arctic Front Advance™ 2AF284

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  3 reports
• Arctic Front Advance™ 2AF234

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports
• Arctic Front Advance™ 2AF234

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports
• Arctic Front Advance™ 2AF234

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports

Recent Arctic Front Advance adverse event reports

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

• InjuryMar 25, 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 INVOLVING BOTH CRYOABLATION AND RADIOFREQUENCY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) ARREST. INITIALLY, THE PULMONARY VEINS WERE ABLATED USING CRYOABLATION. IT WAS NOTED THE PATIENT'S OXYGEN SATURATIONS HAD DROPPED DURING THE LAST FREEZE. THE PATIENT THEN HAD RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER TO ABLATE THE POSTERIOR WALL. PATIENT THEN EXPERIENCED AN EXTREMELY LOW RHYTHM WHICH PROGRESSED TO VENTRICULAR FIBRILLATION. RESUSCITATION MEASURES, WHICH INCLUDED CARDIOPULMONARY RESUSCITATION (CPR) AND EXTERNAL SHOCKS WERE CARRIED OUT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. IT WAS FURTHER NOTED PATIENT HAD SUSTAINED FRACTURED RIBS, POSSIBLY RELATED TO THE CHEST COMPRESSIONS. THE PROCEDURE WAS COMPLETED USING BOTH CRYO AND RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s); Bradycardia; Low Oxygen Saturation; Ventricular Fibrillation

  MAUDE report 21692103 ↗
• MalfunctionJan 29, 2025Compatibility Problem; Infusion or Flow Problem; Material Twisted/Bent; Compatibility Problem; Infusion or Flow Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A MAPPING CATHETER AND A BALLOON CATHETER, THE MAPPING CATHETER WAS UNABLE TO BE MANIPULATED INSIDE THE BALLOON CATHETER, AND IT COULD NOT MOVE FORWARD OR BACKWARD, LEADING TO PHYSICAL DAMAGE. THERE WERE ALSO ISSUES INSERTING THE MAPPING CATHETER INTO THE BALLOON CATHETER. ADDITIONALLY, THE BALLOON CATHETER EXPERIENCED GENERAL EARLY DEFLATION AND PRESSURE/FLOW ISSUES. THE MAPPING CATHETER AND BALLOON CATHETER WERE BOTH REPLACED TO RESOLVE THESE ISSUES. THE PROCEDURE WAS COMPLETED WITH CRYO. IT WAS NOTED THAT IT WAS HARD TO MANIPULATE THE MAPPING CATHETER AND IT WAS BELIEVED THAT THE MAPPING CATHETER WAS KINKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267083 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION PRIOR TO THE INSERTION OF THE SHEATH. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. BASELINE IMAGING WAS OBTAINED TO ASSESS FOR PERICARDIAL EFFUSION PRIOR TO THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED TO ADDRESS THE EFFUSION AND TAMPONADE, WHICH RESULTED IN SYMPTOM RESOLUTION PRIOR TO LEAVING THE LAB. THE CASE WAS ULTIMATELY 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; Pericardial Effusion

  MAUDE report 20891813 ↗
• MalfunctionDec 6, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE NOT AS EXPECTED. THE BALLOON CATHETER AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. AFTER THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, THERE WAS DIFFICULTY PURGING AIR FROM THE SHEATH. THE BALLOON CATHETER WAS REPLACED BUT THE ISSUE REMAINED. THE BALLOON CATHETER WAS REPLACED A THIRD TIME TO RESOLVE THE ISSUES. 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 20869563 ↗
• MalfunctionNov 15, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE FLUCTUATING ERRATICALLY AND THE TEMPERATURE DROPPED MORE QUICKLY THAN EXPECTED, DESPITE BALLOON PLACEMENT IN A WARMER REGION OF THE HEART. THE AUTO CONNECTION BOX WAS REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER WAS REPLACED WITH ONE OF THE SAME LOT, AND THE ISSUES PERSISTED. THE BALLOON CATHETER WAS REPLACED AGAIN WITH ONE OF A NEW LOT 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 20695911 ↗
• MalfunctionNov 15, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE FLUCTUATING ERRATICALLY AND THE TEMPERATURE DROPPED MORE QUICKLY THAN EXPECTED, DESPITE BALLOON PLACEMENT IN A WARMER REGION OF THE HEART. THE AUTO CONNECTION BOX WAS REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER WAS REPLACED WITH ONE OF THE SAME LOT, AND THE ISSUES PERSISTED. THE BALLOON CATHETER WAS REPLACED AGAIN WITH ONE OF A NEW LOT 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 20695902 ↗
• MalfunctionNov 6, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE DROPPING FASTER THAN EXPECTED. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. A BACKUP CONSOLE WAS THEN PUT INTO USE WITH A NEW AUTO CONNECTION BOX, BUT THE CATHETER HAD TO BE REPLACED BECAUSE THE DATE AND TIME ON THE CONSOLE WAS INCORRECT. THE BALLOON CATHETER, ELECTRICAL UMBILICAL CABLE AND AUTO CONNECTION BOX WERE REPLACED TO RESOLVE THE ISSUES. 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 20623161 ↗
• MalfunctionNov 6, 2024Use of Device Problem; Excessive Cooling; Use of Device Problem; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE COLDER FASTER THAN EXPECTED AND THE VEIN COULD NOT BE ISOLATED. SEVERAL FREEZES WERE CARRIED OUT AND THE ISSUE DID NOT RESOLVE. IMAGING CONFIRMED THE BALLOON CATHETER WAS NOT TOO DEEP IN THE VEIN. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. AFTER THE CASE, TEST FREEZES WERE CARRIED OUT WITH THE BALLOON CATHETER. TEMPERATURE ISSUES AND ICE FORMATION WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620627 ↗
• MalfunctionNov 4, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES DROPPED FASTER THAN EXPECTED ON ALL ABLATIONS. THE CONSOLE WAS REBOOTED AND THE ISSUE REMAINED. THE AUTO CONNECTION BOX WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. THE DATA FILES WERE REVIEWED AND TEMPERATURE OSCILLATIONS WERE OBSERVED. AFTER THE PROCEDURE, TEST ABLATIONS WERE PERFORMED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600828 ↗
• MalfunctionOct 22, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE COLDER THAN EXPECTED AT THIRTY SECONDS, RESULTING IN INTERRUPTED ABLATIONS. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE 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 20507972 ↗
• MalfunctionOct 17, 2024Leak/Splash; Excessive Cooling; Infusion or Flow Problem; Protective Measures Problem; Leak/Splash; Excessive Cooling; Infusion or Flow Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE FLOW WAS HIGHER THAN EXPECTED, THERE WERE TEMPERATURE OVERSHOOTS, AND FROST FORMING ON THE COAXIAL CONNECTION. IT WAS ALSO REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE VACUUM WAS DISABLED DUE TO A PROBLEM WITH THE COAXIAL UMBILICAL CABLE. 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 20473230 ↗
• MalfunctionOct 16, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURE FLUCTUATIONS WHERE OBSERVED DURING ABLATIONS. THE TEMPERATURES QUICKLY BECAME VERY COLD. IT WAS CONFIRMED BY FLUOROSCOPY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THEY WERE NOT DEEP INSIDE THE VEIN. THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. 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 20468013 ↗
• MalfunctionOct 16, 2024Use of Device Problem; Excessive Cooling; Use of Device Problem; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE WAS NOT AS EXPECTED SO THE PHYSICIAN STOPPED THE ABLATIONS EARLY FOR PATIENT SAFETY. POST MAPPING WAS PERFORMED USING ANOTHER MANUFACTURER'S DEVICE. THERE WAS MINIMAL EVIDENCE OF ANY ABLATIONS HAVING BEEN DONE, AND EACH OF THE VEINS STILL HAD LOCAL PULMONARY VEIN SIGNALS. A TEST ABLATION WAS PERFORMED IN A STERILE BOWL OF SALINE. THE CONSOLE TEMPERATURES SHOWED VERY RAPID COOLING. THE ICE CAP ON TOP OF THE BALLOON WAS INCONSISTENT AND PART OF THE EXPECTED ICE CAP AREA HAD LITTLE TO NO ICE. THE BALLOON CATHETER WAS REPLACED WITH ANOTHER MODEL BALLOON CATHETER WHICH RESOLVED THE ISSUE. ALL OF THE ABLATIONS WERE REPEATED. THE TEMPERATURE WAS AS EXPECTED. POST MAPPING WAS PERFORMED AGAIN AND IT SHOWED COMPLETE PULMONARY VEIN AND POSTERIOR WALL ISOLATION. 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 20463795 ↗
• MalfunctionOct 16, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE COLDER THAN EXPECTED AND THE TEMPERATURES DROPPED FASTER THAN EXPECTED WITHIN FIFTY SECONDS. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. SUBSEQUENTLY, 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 20462613 ↗
• MalfunctionOct 15, 2024Excessive Cooling; Infusion or Flow Problem; Excessive Cooling; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, FROST WAS SEEN ON THE COAXIAL UMBILICAL CABLE TO CATHETER CONNECTION. THE COAXIAL UMBILICAL CABLE WAS REPLACED WHICH RESOLVED THE ISSUE. IT WAS ALSO REPORTED THAT THE TEMPERATURES WERE COLDER, QUICKER THAN EXPECTED AND THE BALLOON CATHETER THAWED MORE QUICKLY THAN EXPECTED. 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 20455807 ↗

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