Arctic Front Advance™ 2AF284 (UDI 00643169345614)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169345614), received between Dec 19, 2016 and Mar 6, 2017 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT'S PHRENIC NERVE PALSY (PNP) DID RECOVER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 6380124 ↗
• 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, PHRENIC NERVE PALSY (PNP) OCCURRED WHICH RESOLVED PRIOR TO THE PATIENT LEAVING THE CATHETERIZATION LABORATORY. THE PROCEDURE WAS COMPLETED WITH CRYO. THE PNP WAS DETERMINED TO BE A TRANSIENT SYMPTOM. THE PATIENT WAS DISCHARGED ON THE NORMAL SCHEDULE AND NO SYMPTOMS WERE PRESENT AT THE TIME OF DISCHARGE. TWO WEEKS AFTER DISCHARGE, THE PATIENT VISITED THE FACILITY WITH A COMPLAINT OF SUBJECTIVE SYMPTOMS OF SHORTNESS OF BREATH DURING EXERTION. X-RAY PHOTO REVEALED THAT RIGHT DIAPHRAGM WAS HIGHER THAN NORMAL CONDITION AND THE PATIENT WAS DIAGNOSED AS HAVING PHRENIC NERVE PARALYSIS. THE PATIENT IS CURRENTLY RECEIVING POSTOPERATIVE CHECKUPS AND THE SYMPTOMS OF THE PNP REMAIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 6260348 ↗
• InjuryDec 19, 2016No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE PATIENT HAD PHRENIC NERVE INJURY ON THE FIRST FREEZE OF THE RIGHT SUPERIOR PULMONARY VEIN. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS PLACED ON A VENTILATOR DUE TO LOST PHRENIC NERVE CAPTURE IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). AFTER THE PROCEDURE THE PATIENT WAS UPGRADED TO A BIVENTRICULAR ICD, AFTER WHICH THERE WAS PHRENIC NERVE CAPTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 6186240 ↗

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