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Woven M0044FMC007150Recalls & reported problems

Boston Scientific Corporation · Diagnostic Electrode Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729900917), received between Jun 24, 2020 and Jun 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Poor Quality Image” (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

Device problems

  • Poor Quality Image1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 24, 2020Poor Quality Image; Poor Quality Image

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12 JUN 2020. IT WAS REPORTED THAT THE CATHETER HAD NOISY ELECTROGRAMS. DURING AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WOVEN DIAGNOSTIC ELECTRODE CATHETER, ABOUT 2 HOURS INTO THE PROCEDURE, NOISE APPEARED ON ELECTRODES 1-2 AND 3-4 DURING CONNECTION. THE CATHETER CABLE WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. DEVICE ANALYSIS FOUND FOREIGN MATERIAL AT THE DISTAL ELECTRODE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10188684 ↗

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.