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Viking™ M0044001000Recalls & reported problems

Boston Scientific Corporation · Fixed Curve Diagnostic Catheter · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729878872), received between Jul 30, 2020 and Aug 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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

Device problems

  • Defective Device2
  • Device Markings/Labelling Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2023Defective Device; Defective Device

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE A VIKING 6F ELECTRODE CATHETER WAS SELECTED FOR USE. UPON UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT A BOSTON SCIENTIFIC POST MARKET LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17625864 ↗
  • MalfunctionOct 8, 2021Defective Device; Defective Device

    DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT "THERE WAS ERROR IN THE MACHINE" AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12598577 ↗
  • MalfunctionJul 30, 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. DURING AN ARRHYTHMIA PROCEDURE IN THE HEART A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. THE MODEL OF THE DEVICE WAS DIFFERENT FROM THE OUTER PACKAGE AND INNER PACKAGE. THE OUTER PACKAGE WAS LABELED FIXED CURVE DIAGNOSTIC CATHETER 10E, BUT THE INNER PACKAGE WAS LABELED DIAGNOSTIC CATHETER 4E. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10343634 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.