Viking™ M0044000040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729878049), received between Jan 9, 2020 and Dec 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE, MOVE OR STEER, AND WITHDRAW. A KINK WAS ALSO OBSERVED. DURING AN ELECTROPHYSIOLOGY PROCEDURE TO TREAT ATRIAL FIBRILLATION, A VIKING ELECTRODE CATHETER WAS USED. UPON INSERTION, THE CATHETER BECAME DIFFICULT TO ADVANCE, MOVE OR STEER, AND WITHDRAW IN THE VEIN. THE CATHETER WAS ALSO BENT AND KINKED. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED, PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679768 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERFORATION OCCURRED. DURING A BOSTON SCIENTIFIC DEFIBRILLATOR & LEAD IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO CANNULATE THE CORONARY SINUS WITH AN ACUITY PRO GUIDE CATHETER AND A VIKING ELECTRODE CATHETER. DURING THE FIRST ATTEMPT AT CANNULATION, ANGIOGRAPHY SHOWED CONTRAST DYE AROUND THE CARDIAC PROFILE. THE PHYSICIAN CONCLUDED THE IMPLANT PROCEDURE, IMPLANTING A LEFT VENTRICULAR LEAD. THE PATIENT WAS TRANSFERRED TO CARDIOSURGERY WHERE LIQUID DYE AND BLOOD WERE DRAINED TO AVOID PERICARDIAL TAMPONADE. IT WAS NOT POSSIBLE TO DETERMINE WHICH DEVICE(S) HAD CAUSED OR CONTRIBUTED TO THE PERFORATION; IT WAS NOTED THAT "MAYBE BOTH" HAD CONTRIBUTED. AS OF (B)(6) 2019, THE PATIENT WAS "FINE" BUT REMAINED HOSPITALIZED.

  Patient problems: Cardiac Perforation

  MAUDE report 9570571 ↗