Arctic Front Advance™ 2AF284 (UDI 00643169504783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169504783), received between Jan 18, 2017 and Feb 24, 2017 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS MANIPULATED IN THE LEFT ATRIUM, THE PATIENT'S TRANSIENT BLOOD-PRESSURE DROPPED AND THE HEART RATE INCREASED. NORADRENALIN, SALT SOLUTION AND VASOLAN WERE ADMINISTERED AND BLOOD PRESSURE WAS REGAINED. THE HEALTHCARE PROFESSIONAL NOTED THIS MAY HAVE BEEN DUE TO DEHYDRATION. ADDITIONALLY, BLEEDING OCCURRED FROM THE INGUINAL REGION WHERE THE SHEATH WAS INSERTED. WHEN THE PATIENT LEFT AN OPERATION ROOM, STABLE CARDIOHEMODYNAMICS WERE OBSERVED. NO PERICARDIAL EFFUSION WAS CONFIRMED AND THE PATIENT RESPONDED NORMALLY WHEN THE PHYSICIAN TALKED TO PATIENT. THE PATIENT'S FOUR LIMBS MOTION WAS NORMAL. A PHYSICIAN TAKING CARE OF THE PATIENT COMMENTED THAT A VESSEL NEAR THE VEIN WAS POSSIBLY DAMAGED FROM THE SIDE WHERE THE SHEATH WAS INSERTED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 6356778 ↗
• InjuryFeb 20, 2017Adverse 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 BALLOON CATHETER WAS ADVANCED INTO THE PERICARDIUM. IT WAS CONCLUDED THAT THERE WAS A SMALL PERICARDIAL EFFUSION WHICH LEAD TO AN EXTENDED HOSPITAL STAY. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. SURGICAL INTERVENTION WAS PERFORMED TO DRAIN THE FLUID FROM THE PATIENT¿S PERICARDIUM. THE PATIENT RECOVERED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 6344256 ↗
• InjuryJan 27, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING TO A CRYO ABLATION PROCEDURE, A KINK WAS OBSERVED IN THE TUBING UNDER THE BALLOON FOLLOWED BY A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE CASE WAS ABORTED AND 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 6283009 ↗
• InjuryJan 26, 2017Adverse 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 A THROMBUS THAT WAS OBSERVED ON THE LEFT CARINA VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CASE WAS COMPLETED WITH CRYO. THE PATIENT'S STAY WAS EXTENDED A DAY AT THE HOSPITAL AND THE PATIENT WAS DISCHARGED WITH AN EXTRA DOSE OF MEDICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombus

  MAUDE report 6279456 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST CRYO ABLATION PROCEDURE, A POST-OPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED "SEVERE" PULMONARY VEIN (PV) STENOSIS IN THE LEFT INFERIOR PULMONARY VEIN. A BALLOON DILATION WAS PERFORMED TO CORRECT THE STENOSIS. THE ORIGINAL PROCEDURE WAS COMPLETED WITH CRYO AND NO SYMPTOMS WERE REPORTED BY THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stenosis

  MAUDE report 6261477 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE MOVEMENT OF THE DIAPHRAGM WAS WEAKENED DURING ABLATION OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE CONDITION IMPROVED AND ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WAS PERFORMED AND PHRENIC NERVE PALSY (PNP) OCCURRED. THE PROCEDURE WAS COMPLETED WITH CRYO BUT THE DIAPHRAGM WAS ONLY WORKING SLIGHTLY WHEN THE PATIENT LEFT THE OPERATING ROOM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 6260557 ↗

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