Dynamic XT™ M0046DYNXT0090Recalls & reported problems
Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2
All models of Dynamic XT (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729879893), received between Aug 27, 2019 and Aug 27, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pericardial Effusion1
- Vaso-Vagal Response1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND A VASOVAGAL RESPONSE. DURING A VENTRICULAR CONTRACTION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING ABLATION ON THE BASAL SEPTAL WALL OF THE LEFT VENTRICULAR, THE PATIENT EXPERIENCED A VAGAL RESPONSE. AN EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAM AND WAS THOUGHT TO BE LOCATED FROM THE APEX OF THE LEFT VENTRICLE (LV). PROTAMINE SULFATE WAS USED TO REVERSE THE EFFECTS OF HEPARIN. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PHYSICIAN ALLEGED THE EFFUSION TO THE ABLATION CATHETER, BUT COULD NOT BE SURE.
Patient problems: Pericardial Effusion; Vaso-Vagal Response
MAUDE report 8936392 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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