Arctic Front Advance Pro™ AFAPRO23 (UDI 00763000707774)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000707774), received between Apr 25, 2025 and Aug 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE USING THE CATHETER AFAPRO23 AFA PRO 23, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION AFTER THE FIRST CRYO ABLATION IN THE LEFT INFERIOR PULMONARY VEIN. FREEZE PARAMETERS WERE NORMAL AT -63 DEGREES FOR 180 SECONDS, AND THE ONSET OF ST SEGMENT ELEVATION OCCURRED 2 MINUTES AND 45 SECONDS INTO THE FREEZE. INTERVENTIONAL CARDIOLOGY WAS CONTACTED, AND 10MG INTRAVENOUS VASODILATOR MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. CORONARY ANGIOGRAPHY REVEALED COMPLETED OCCLUSION OF THE RIGHT CORONARY ARTERY AND CHRONIC CORONARY ARTERY DISEASE IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. THE PATIENT EXHIBITED SMALL RUNS OF VENTRICULAR TACHYCARDIA AND PREMATURE VENTRICULAR CONTRACTIONS, WHICH WERE TREATED WITH 150MG OF AN ANTIARRHYTHMIC MEDICATION. AN INTERVENTIONALIST INJECTED 300MCG INTRACORONARY VASODILATOR MEDICATION INTO THE AORTIC ROOT/RIGHT CORONARY ARTERY, WHICH IMMEDIATELY RESOLVED THE ST SEGMENT ELEVATION. THE EVENT WAS DIAGNOSED AS ACUTE CORONARY SPASM. THE PATIENT WAS STABLE, TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MEDICAL MANAGEMENT, AND UNDERWENT A COMPUTED TOMOGRAPHY SURG

  Patient problems: Cramp(s) /Muscle Spasm(s); Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 22772114 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. CONTINUE WAS PRESSED AND TRIED TO FREEZE AGAIN, WITHOUT RESOLUTION. THE VACUUM WAS RELEASED AND A SYSTEM FLUSH WAS PERFORMED, BUT THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. THE BALLOON CATHETER WAS REPLACED, BUT THEN THE FIRST TWO SYSTEM NOTICES WERE RECEIVED AGAIN, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CONSOLE AND THE SYSTEM WAS INOPERABLE, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. "EVERYTHING WAS REMOVED," BUT THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CONSOLE AND THE SYSTEM IN INOPERABLE. FLUID WAS FOUND IN THE COAXIAL UMBILICAL CABLE AND ON THE COAXIAL PORT OF THE CONSOLE. THE CASE WAS COMPLETED WITH CRYO. TEST ABLATIONS WERE LATER PERFORMED WITH A NEW BALLOON CATHETER AND COAXIAL UMBILICAL CABLE, AND NO ISSUES WERE OBSERVED. NO PATIENT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909141 ↗

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