Viking™ M0044000070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729878070), received between Nov 10, 2021 and Dec 2, 2021 — classified as 3 injuries, 1 malfunction.

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

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. How this data works · Data updated Oct 13, 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.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920900 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920784 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920712 ↗
• MalfunctionNov 10, 2021Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING PREPARATION ON THE VIKING ELECTRODE CATHETER, THE "SHAFT OF THE CATHETER TO THE CONNECTION WAS HUNG ON AN EXPOSED CABLE". THE CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS STILL COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787167 ↗