Arctic Front Advance™ 2AF284 (UDI 00643169878365)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169878365), received between Feb 12, 2020 and Jul 22, 2021 — classified as 1 death, 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A CRYOABLATION PROCEDURE, THE BALLOON CATHETER BROKE AT THE TUOHY VALVE CONNECTION. IT WAS NOTED THAT NO ABNORMAL FORCE WAS USED DURING PREPARATION. THE BALLOON CATHETER WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211988 ↗
• MalfunctionFeb 4, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282654 ↗
• MalfunctionJan 7, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, THE PHYSICIAN COULD NOT PREVENT AIR FROM STOPPING WHEN ASPIRATING. A HEMOSTATIC VALVE ISSUE WAS SUSPECTED. THE SHEATH WAS REPLACED, BUT WHEN THE BALLOON CATHETER WAS INSERTED, A STREAM OF AIR BUBBLES WAS NOTED. IT WAS NOTED THE BALLOON CATHETER WAS A TIGHT FIT GOING INTO THE SHEATH. THE BALLOON CATHETER WAS REPLACED, RESOLVING 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 11132148 ↗
• MalfunctionDec 14, 2020Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002115 ↗
• MalfunctionDec 7, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, BUBBLES WERE NOTED IN THE BALLOON CATHETER WHEN PULLING IT BACK. THE BALLOON CATHETER WAS REPLACED, RESOLVING 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 10959972 ↗
• MalfunctionNov 30, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE LUER OF THE BALLOON CATHETER BROKE. THIS HAPPENED AGAIN TO ANOTHER BALLOON CATHETER. THE BALLOON CATHETER WAS REPLACED AGAIN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920972 ↗
• MalfunctionNov 30, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE LUER OF THE BALLOON CATHETER BROKE. THIS HAPPENED AGAIN TO ANOTHER BALLOON CATHETER. THE BALLOON CATHETER WAS REPLACED AGAIN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920960 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE LUER PORT OF THE BALLOON CATHETER BROKE. 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; No Consequences Or Impact To Patient

  MAUDE report 10824100 ↗
• InjuryOct 26, 2020Adverse 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 DEVELOPED A CARDIAC TAMPONADE WITH PERICARDIAL EFFUSION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE EFFUSION WAS DRAINED AND THE PATIENT HOSPITALIZED FOR AN EXTRA DAY FOR MONITORING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 10738544 ↗
• InjuryOct 23, 2020Adverse 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. A DOUBLE STOP WAS PERFORMED. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE PNP RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 10729244 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CRYO ABLATION PROCEDURE THAT WAS COMPLETED WITH CRYO, IT WAS NOTED THE PATIENT HAD A PERICARDIAL EF FUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT TAKEN TO THE OPERATING ROOM. THE PATIENT RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 10715859 ↗
• MalfunctionSep 30, 2020Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10608272 ↗
• MalfunctionSep 15, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS WAS OBSERVED AFTER THE BALLOON CATHETER WAS INSERTED. THE SHEATH WAS REPLACED WITHOUT RESOLUTION. THEN THE BALLOON CATHETER WAS REPLACED, AND THE ISSUE WAS NOT RESOLVED. THE BALLOON CATHETER WAS EVENTUALLY ALIGNED COAXIALLY, 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 Consequences Or Impact To Patient

  MAUDE report 10536542 ↗
• MalfunctionSep 15, 2020Gas/Air Leak; Material Twisted/Bent; Gas/Air Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN TRYING TO PULL BACK HEME, IF THE PHYSICIAN PULLED THE SYRINGE TOO FAST, AIR WAS INTRODUCED. THE SHEATH WAS REPLACED. THE PHYSICIAN IS NOT SURE IF THE SHEATH OR BALLOON CATHETER WERE CAUSING THE AIR INGRESS ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536366 ↗
• MalfunctionSep 11, 2020Material 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 Consequences Or Impact To Patient

  MAUDE report 10521400 ↗
• InjuryAug 4, 2020Adverse 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 PHRENIC NERVE PALSY (PNP). THE CASE WAS SWITCHED TO AND COMPLETED WITH RADIOFREQUENCY. THE PNP HAD NOT RECOVERED WHEN THEY WERE DISCHARGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 10362704 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN PREPPING THE BALLOON CATHETER FOR USE, THE LUER LOCK ON THE BALLOON CATHETER HANDLE BROKE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10015702 ↗
• MalfunctionApr 2, 2020Device Contamination with Body Fluid; Infusion or Flow Problem; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Device Contamination with Body Fluid; Infusion or Flow Problem; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS SEEN ON THE BALLOON CATHETER CONNECTION. 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 Known Impact Or Consequence To Patient

  MAUDE report 9917262 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHILE MANIPULATING THE SHEATH, THE SHEATH, BALLOON CATHETER, AND MAPPING CATHETER FELL BACK INTO THE RIGHT ATRIUM, INDUCING TACHYCARDIA. A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE, AND THE CASE WAS COMPLETED WITH CRYO. THE PATIENTS HOSPITALIZATION STAY WAS EXTENDED THREE DAYS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Pericardial Effusion

  MAUDE report 9913805 ↗
• DeathMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL CRYO ABLATION PROCEDURE, PERICARDIAL EFFUSION WAS EVIDENT THROUGH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. MEASURES WERE TAKEN TO OPTIMIZE BLOOD PRESSURE AND HEART RATE. PERICARDIOCENTESIS, OPEN CHEST PROCEDURE, CARDIOPULMONARY RESUSCITATION (CPR), AND BLOOD TRANSFUSIONS WERE PERFORMED. THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade; Death; Pericardial Effusion

  MAUDE report 9879081 ↗
• MalfunctionMar 3, 2020Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS VISIBLE IN THE COAXIAL/CATHETER CONNECTION. BLOOD WAS ALSO NOTED IN THE COAXIAL PORT ON THE CONSOLE, HOWEVER, THERE WAS NO BLOOD IN THE BLOOD BOTTLE. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE 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 9781757 ↗
• InjuryFeb 13, 2020Adverse 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 PHRENIC NERVE PALSY (PNP). THE CASE WAS ABORTED WITH PATIENT UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 9708848 ↗
• InjuryFeb 12, 2020Adverse 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 SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. THE PROCEDURE WAS CONTINUED. IT WAS NOTED THAT THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WAS DIFFICULT TO ACCESS DUE TO PATIENT ANATOMY. THE BALLOON CATHETER AND MAPPING CATHETER WERE REMOVED, AND ANOTHER CATHETER WAS USED TO POSITION THE SHEATH NEAR THE RSPV OSTIUM. THE CATHETER WAS REMOVED AND THE BALLOON CATHETER WAS REINSERTED. UPON THE FIRST INFLATION AT THE RSPV IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS DROPPING AND AN EFFUSION WAS NOTED ON FLUOROSCOPY. THE BALLOON CATHETER AND SHEATH WERE REMOVED FROM THE ATRIUM AND A PERICARDIOCENTESIS WAS PERFORMED. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. DUE TO THE AMOUNT OF DRAINAGE, THE PATIENT WAS SENT FOR SURGERY AND A SMALL PERFORATION NEAR THE RSPV WAS NOTED. THE PERFORATION WAS REPAIRED AND 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; Pericardial Effusion

  MAUDE report 9702387 ↗

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