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Dynamic XT™ M0042011050Recalls & reported problems

Boston Scientific Corporation · Unidirectional Steerable Diagnostic 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 08714729877653), received between Oct 7, 2019 and Oct 7, 2019 — 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.

  • MalfunctionOct 7, 2019Poor Quality Image; Poor Quality Image

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13SEP2019. DURING AN ABLATION PROCEDURE WITH A DYNAMIC XT, THE CARTO WAS MAKING A LOT OF NOISE. THE CATHETER WAS REPLACED AND THE REPLACEMENT WAS USED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, DEVICE ANALYSIS REVEALED A GOUGE IN THE DISTAL END SHAFT WITH A PIECE OF SHAFT MATERIAL LIFTED BUT SECURELY ATTACHED TO THE DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9161840 ↗

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.