Viking™ M0044000470Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729878476), received between Mar 19, 2019 and Nov 22, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. AN ABLATION PROCEDURE WAS BEING PERFORMED FOR ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA (AVRT). AFTER THE ELECTROPHYSIOLOGY (EP) STUDY WAS PERFORMED AND A LEFT LATERAL PATHWAY WAS FOUND, THE PHYSICIAN USED A BLAZER PRIME HTD TO ABLATE THE PATHWAY. THEY DID NOT HAVE SUCCESS AND FELT HE COULDN'T REACH FAR ENOUGH AND WITHDRAW THE CATHETER TO CHECK THE MECHANISM. ON REMOVAL OF THE CATHETER, THE PHYSICIAN SHOWED THAT THE DEFLECTOR MECHANISMS OF THE BLAZER PRIME HTD WAS NOT WORKING. THE CATHETER'S DEFLECTION MECHANISM WAS FAULTY; IT DID NOT DEFLECT. A NEW BLAZER OPEN-IRRIGATED CATHETER WAS INSERTED AND THE PROCEDURE CONTINUED. THEY CONTINUED THE PROCEDURE AND A BLOCK WAS ACHIEVED. THE PHYSICIAN THEN NOTED THAT THE PATIENT'S BLOOD PRESSURE (BP) HAD DROPPED AND PULSE RATE INCREASED. THEY PERFORMED A CARDIAC ULTRASOUND AND FOUND A LARGE PERICARDIAL EFFUSION, WHICH WAS DRAINED. THE PATIENT WAS DISCHARGED TO INTENSIVE CARE UNIT (ICU) WITH A PERICARDIAL DRAIN IN PLACE AND WAS IN THE ICU OVERNIGHT. SHE WAS IN HOSPITAL UNTIL THE (B)(6) 2019, WHEN SHE WAS DISCHARGED HOME. THE PERICARDIAL EFFUSION RESOLVED AND PATIENT WAS IN SIN

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 9363920 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. AN ABLATION PROCEDURE WAS BEING PERFORMED FOR ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA (AVRT). AFTER THE ELECTROPHYSIOLOGY (EP) STUDY WAS PERFORMED AND A LEFT LATERAL PATHWAY WAS FOUND, THE PHYSICIAN USED A BLAZER PRIME HTD TO ABLATE THE PATHWAY. THEY DID NOT HAVE SUCCESS AND FELT HE COULDN'T REACH FAR ENOUGH AND WITHDRAW THE CATHETER TO CHECK THE MECHANISM. ON REMOVAL OF THE CATHETER, THE PHYSICIAN SHOWED THAT THE DEFLECTOR MECHANISMS OF THE BLAZER PRIME HTD WAS NOT WORKING. THE CATHETER'S DEFLECTION MECHANISM WAS FAULTY; IT DID NOT DEFLECT. A NEW BLAZER OPEN-IRRIGATED CATHETER WAS INSERTED AND THE PROCEDURE CONTINUED. THEY CONTINUED THE PROCEDURE AND A BLOCK WAS ACHIEVED. THE PHYSICIAN THEN NOTED THAT THE PATIENT'S BLOOD PRESSURE (BP) HAD DROPPED AND PULSE RATE INCREASED. THEY PERFORMED A CARDIAC ULTRASOUND AND FOUND A LARGE PERICARDIAL EFFUSION, WHICH WAS DRAINED. THE PATIENT WAS DISCHARGED TO INTENSIVE CARE UNIT (ICU) WITH A PERICARDIAL DRAIN IN PLACE AND WAS IN THE ICU OVERNIGHT. SHE WAS IN HOSPITAL UNTIL THE (B)(6) 2019, WHEN SHE WAS DISCHARGED HOME. THE PERICARDIAL EFFUSION RESOLVED AND PATIENT WAS IN SIN

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 9363799 ↗
• MalfunctionMar 19, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. A VIKING ELECTRODE CATHETER WAS SELECTED FOR A ELECTROPHYSIOLOGY PROCEDURE. HOWEVER BEFORE THE CATHETER WAS USED IT WAS NOTICED THAT THE CATHETER WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433588 ↗