Arctic Front Advance™ 2AF284 (UDI 00643169939318)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169939318), received between Sep 7, 2018 and Jul 10, 2023 — classified as 1 death, 25 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (25 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 75 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER CONFIRMED THAT THE BALLOON CATHETER WAS NOT EXPIRED.

  Patient problems: Cardiac Tamponade

  MAUDE report 17292810 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVE TO A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED "PERICARDIAL PAIN". THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 9819485 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SUCCESSFULLY COMPLETED CRYO ABLATION, PHRENIC NERVE PALSY (PNP) WAS OBSERVED AND THE PATIENT WAS DISCHARGED WITHOUT RECOVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 8956115 ↗
• MalfunctionJun 24, 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, AFTER THE BALLOON CATHETER WAS RE-ENTERED INTO THE PATIENT¿S BODY FOR A TOUCH UP ABLATION, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION AND BLOOD WAS OBSERVED IN THE COAXIAL CONNECTION PORT. THE PROCEDURE WAS COMPLETED WITH CRYO. THIS PATIENT IS PART OF THE (B)(6) CLINICAL STUDY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8728996 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER LUER BROKE OFF. 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 8717911 ↗
• MalfunctionMay 30, 2019Material Integrity Problem; Material Integrity Problem

  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 8656013 ↗
• MalfunctionMay 28, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE,WHEN A REPLACEMENT BALLOON CATHETER WAS OPENED, THE SEGMENT PROXIMAL TO THE BALLOON APPEARED CRIMPED. THE BALLOON CATHETER WAS NOT DEFLECTING IN PLANE, AND IT WAS NOTED ONE OF THE PULL WIRES MAY HAVE BEEN BROKEN. THE BALLOON CATHETER WAS REPLACED WITH RESOLVE, AND 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 8647242 ↗
• MalfunctionMay 20, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624025 ↗
• InjuryMay 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, DURING A FREEZE IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), BLOOD WAS OBSERVED IN THE ENDOTRACHEAL (ET) TUBE. ALL DEVICES WERE PULLED FROM THE LEFT ATRIUM AND INTO THE INFERIOR VENA CAVA. AN EMERGENCY BRONCHOSCOPY WAS PERFORMED AND ACTIVE BLEEDING WAS SEEN IN BOTH LUNGS. MEDICATION WAS ADMINISTERED TO LOWER THE ACTIVATED CLOTTING TIME (ACT) VALUE. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA AND THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION INDICATED A COMPUTERIZED TOMOGRAPHY (CT) SCAN FOUND THE PATIENT HAD A PRE-EXISTING ARTERIOVENOUS MALFORMATION. BLEEDING HAD STOPPED THE DAY OF THE EVENT AND THE PATIENT WAS SENT HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8617988 ↗
• MalfunctionMay 16, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; 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 8616569 ↗
• MalfunctionMay 13, 2019Material Deformation; Material Twisted/Bent; Material Deformation; 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 8604520 ↗
• InjuryMay 10, 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 ABLATION WAS STOPPED AND THE PNP WAS MONITORED. THE PNP HAD NOT RECOVERED AT THE END 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 8600892 ↗
• InjuryMay 9, 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 CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS GIVEN OXYGEN THERAPY ON DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Nerve Damage

  MAUDE report 8596507 ↗
• MalfunctionMay 9, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595595 ↗
• InjuryMay 7, 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 WHEN ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). A DOUBLE-STOP MANEUVER WAS PERFORMED ON THE CONSOLE, AND THE PNP RESOLVED. THE CASE WAS COMPLETED WITH CRYO. HOWEVER, IT WAS NOTED THAT THE PATIENT RETURNED TO THE CLINIC AT A LATER DATE WITH PNP, WHICH IS CURRENTLY UNRESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 8587919 ↗
• InjuryMay 7, 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 CASE WAS COMPLETED WITH CRYO. THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE; HOWEVER, IT WAS UNKNOWN IF THE PNP FULLY RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 8587073 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE FLUID PORT OF THE BALLOON CATHETER BROKE OFF. 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 8586623 ↗
• DeathApr 24, 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 RIGHT INFERIOR PULMONARY VEIN (RIPV) WAS PERFORATED. ADDITIONALLY, THE PHYSICIAN NOTICED BLOOD IN THE ENDOTRACHEAL (ET) TUBE. BLOOD WAS SUCTIONED FROM THE ET TUBE, BUT BLEEDING CONTINUED, AND THE CASE HAD TO BE ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT IS DECEASED.

  Patient problems: Death; Great Vessel Perforation

  MAUDE report 8547186 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER LUER BROKE. 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 8514193 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CRYOABLATION PROCEDURE THAT WAS COMPLETED WITH CRYO, THE PATIENT WAS NOTED TO BE HYPOTENSIVE OVERNIGHT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING, WHERE HE RECEIVED VASOPRESSOR SUPPORT. PHENYLEPHRINE WAS GIVEN INTRAVENOUSLY, AND ORAL SOTALOL AND LOSARTAN WERE DISCONTINUED. A LIMITED ECHOCARDIOGRAM WAS PERFORMED AND EFFUSION WAS RULED OUT. HEMOGLOBIN WAS CHECKED PERIODICALLY AND FOUND TO BE STABLE. THE PATIENT WAS DISCHARGED. THE EPISODE OF HYPOTENSION WAS DETERMINED TO BE SECONDARY TO ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8499406 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED THAT THE BALLOON CATHETER LUER BROKE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8465856 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SALINE INJECTION PORT OF THE BALLOON CATHETER BROKE OFF. 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 8457915 ↗
• MalfunctionMar 21, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; 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 8442454 ↗
• MalfunctionMar 19, 2019Break; Material Deformation; Break; Material Deformation

  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 8431138 ↗
• MalfunctionMar 11, 2019Break; Break

  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 8409514 ↗

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