Arctic Front Advance Pro™ AFAPRO28 (UDI 00643169889903)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169889903), received between Apr 25, 2019 and Apr 21, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PRE-SYNCOPAL SYMPTOMS COMPLAINING OF DIZZINESS AND LIGHTHEADEDNESS; THE PATIENT WAS REPORTED TO BE PALE. FURTHER EXAMINATION OF THE PATIENT REVEALED THE PATIENT TO HAVE HYPOTENSION, A VASOVAGAL RESPONSE, AND BLOOD IN THEIR STOOL. THE PATIENT WAS TREATED WITH FLUIDS AND INTRAVENOUS MEDICATION AND ADMITTED FOR HOSPITALIZATION. ACUTE GI (GASTROINTESTINAL) BLEED WAS NOTED. AN ECHOCARDIOGRAM SHOWED A TRIVIAL PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension; Pericardial Effusion; Vaso-Vagal Response

  MAUDE report 9981536 ↗
• MalfunctionMay 14, 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 8609555 ↗
• MalfunctionMay 6, 2019Material 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 Known Impact Or Consequence To Patient

  MAUDE report 8582822 ↗
• MalfunctionApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON WAS KINKED. 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 8552003 ↗

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