Viking™ M0044000100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729878100), received between Aug 4, 2020 and Dec 15, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE USING A VIKING DIAGNOSTIC CATHETER THE DEVICE "WAS WRAPPED INTO THE PATIENT" DURING THE PROCEDURE AND BECAME DIFFICULT TO REMOVE. THEY WERE ABLE TO REMOVE THE CATHETER WITHOUT ADDITIONAL INTERVENTIONS AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF BY THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987541 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RADIOFREQUENCY (RF) ABLATION WITH A VIKING ELECTRODE CATHETER AND AN INTELLANAV MIFI OPEN-IRRIGATED VIA A 8F SHEATH WAS BEING PERFORMED TO TREAT PREMATURE VENTRICULAR CONTRACTIONS. THE PHYSICIAN PERFORMED ABLATION AFTER 3D MAPPING. THE PHYSICIAN FOUND THE MAPPING POSITION HAD SHIFTED, BUT THE SYSTEM DID NOT ALERT AN ERROR. ABOUT FIFTEEN MINUTES INTO ABLATION, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION NEAR THE LEFT AORTO-MITRAL CONTINUITY (AMC) ORIGIN, SO THE PHYSICIAN STOPPED THE ABLATION. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS. THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR FURTHER OBSERVATION AFTER THEY WERE STABILIZED. HOWEVER, THE PATIENT DIED ON (B)(6) 2020 DUE TO CONDITION DETERIORATION. THE PATIENT'S OFFICIAL CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION. THE DEVICES ARE EXPECTED TO BE RETURNED. IT WAS REPORTED THAT THE MAPPING POSITION SHIFT DID NOT CAUSE OR CONTRIBUTE TO THE PERICARDIAL EFFUSION AND SUBSEQUENT DEATH. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETERS.

  Patient problems: Death; Myocardial Infarction; Pericardial Effusion

  MAUDE report 10781456 ↗
• MalfunctionAug 4, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL ON THE OUTER PACKAGE WAS DIFFERENT THAN THE LABEL ON THE INNER PACKAGE.A VIKING CATHETER WAS SELECTED FOR USE. THE MODEL ON THE OUTER PACKAGE WAS FIXED CURVE CATHETER 4E, BUT THE MODEL ON THE INNER ASEPTIC PACKAGE WAS FIXED CURVE CATHETER 10E AND THE DEVICE WAS A FIXED CURVE CATHETER 10E AN EXCHANGE OF THE CATHETER RESOLVED THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10361683 ↗