Arctic Front Advance™ 2AF284 (UDI 00643169976382)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169976382), received between Jul 15, 2019 and Aug 19, 2021 — classified as 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A COMPLETED CRYO-ABLATION PROCEDURE, THE PATIENT HAD HEART ARRHYTHMIAS THAT INCLUDED PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA AND ATRIAL TACHYCARDIA. THE PATIENT HAD A REPEAT RADIOFREQUENCY ABLATION. AN ANTIARRHYTHMIC MEDICATION WAS ALSO GIVEN. THE ARRHYTHMIAS 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: Arrhythmia; Tachycardia

  MAUDE report 12342456 ↗
• MalfunctionDec 21, 2020Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047000 ↗
• InjuryMay 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ADVERSE EVENT RESOLVED.

  Patient problems: Dyspnea; Heart Failure; High Blood Pressure/ Hypertension; Hypoxia; Low Cardiac Output; Pneumonia; Pulmonary Edema; Pulmonary Valve Stenosis; Respiratory Failure; Stenosis; Syncope

  MAUDE report 10085728 ↗
• InjuryMar 4, 2020Adverse 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 WAS DIAGNOSED WITH PERICARDITIS. NO INTERVENTION WAS NEEDED AS THE ISSUE RESOLVED ON IT'S OWN. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inflammation

  MAUDE report 9786802 ↗
• MalfunctionJan 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON WAS PRE-INFLATED OUTSIDE THE BODY TO REMOVE AIR BUBBLES AND DURING PRE-INFLATION, A KINK WAS OBSERVED. THE BALLOON CATHETER 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 9558777 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INCOMING INFORMATION INDICATES THE PATIENT RECOVERED.

  Patient problems: Cardiac Perforation; No Code Available

  MAUDE report 9427483 ↗
• InjuryNov 25, 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, PHRENIC NERVE PALSY (PNP) OCCURRED AND THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE PNP RECOVERED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE ANTICIPATED DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 9372645 ↗
• MalfunctionOct 30, 2019Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255174 ↗
• MalfunctionOct 28, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PACKAGING, IT WAS OBSERVED THERE WAS A KINK IN THE BALLOON. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE FOR THE PROCEDURE. 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 9247046 ↗
• MalfunctionOct 28, 2019Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9246635 ↗
• InjuryOct 11, 2019Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity 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 ALONG WITH ANOTHER SYSTEM NOTICE INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. BLOOD WAS FOUND IN THE COAXIAL CONNECTOR. THE BALLOON APPEARED TO BE DAMAGED. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178717 ↗
• 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: Chest Pain; Inflammation; Pneumonia

  MAUDE report 9176801 ↗
• MalfunctionSep 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER INNER LUMEN WAS NOTED TO BE BENT. THE BALLOON CATHETER WAS REPLACED. THE CASE WAS 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 9109998 ↗
• InjurySep 16, 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, PHRENIC NERVE PALSY (PNP) OCCURRED. THE PNP HAD NOT RECOVERED AT THE END OF THE PROCEDURE OR PRIOR TO DISCHARGE. 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 9074064 ↗
• MalfunctionSep 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE INNER PART OF THE BALLOON CATHETER APPEARED TO HAVE A KINK. THE BALLOON CATHETER 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 8982300 ↗
• MalfunctionSep 6, 2019Device Contamination with Body Fluid; Material Integrity Problem; Material Twisted/Bent; Device Contamination with Body Fluid; Material Integrity Problem; Material Twisted/Bent

  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. BLOOD WAS OBSERVED TO FLOW BACK INTO THE COAXIAL UMBILICAL CABLE. THE COAXIAL UMBILICAL CABLE WAS DISCONNECTED, AND THE CASE WAS 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 8968195 ↗
• 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 8956201 ↗
• 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 8941834 ↗
• InjuryAug 15, 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 PATIENT'S BLOOD PRESSURE STARTED TO DECREASE AND THE PATIENT 'CODED;' ADVANCED CARDIAC LIFE SUPPORT WAS PROVIDED INCLUDING DRUGS, CARDIOPULMONARY RESUSCITATION, AND OXYGEN. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA, AND THE PATIENT WAS TRANSFERRED TO CARDIOVASCULAR SURGERY. THE PATIENT HAD OPEN HEART SURGERY TO REPAIR A TEAR IN THEIR LEFT SUPERIOR PULMONARY VEIN AND AS A RESULT, THEIR HOSPITAL STAY WAS EXTENDED. IT WAS NOTED THAT THE PATIENT HAD NO APPARENT DEFICITS IN BRAIN ACTIVITY OR MOVEMENT AND RECOVERED FULLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiopulmonary Arrest; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 8898925 ↗
• MalfunctionAug 15, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK WAS NOTICED ON FLUOROSCOPY TO THE DISTAL END OF THE CATHETER WITHIN THE BALLOON ITSELF. THE BALLOON CATHETER 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 8898763 ↗
• MalfunctionAug 12, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8885357 ↗
• MalfunctionAug 5, 2019Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, PRIOR TO OPENING THE BALLOON CATHETER, A SMALL "FUZZ" WAS OBSERVED INSIDE THE PACKAGING. THE PRODUCT 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 8862191 ↗
• MalfunctionAug 5, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK WAS NOTED IN THE BALLOON OF THE BALLOON CATHETER. THE BALLOON CATHETER 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 8860541 ↗
• 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 8818083 ↗
• MalfunctionJul 15, 2019Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CO-PILOT WAS COMING OFF THE BALLOON GUIDEWIRE LUMEN DURING THE INJECTION. THE BALLOON CATHETER 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 8791607 ↗

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