Dynamic XT™ M0046DYNXT0110Recalls & 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 08714729879909), received between May 25, 2021 and May 25, 2021 — 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
- Ischemia Stroke1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A RHYTHMIA MAPPING AND ABLATION PROCEDURE WAS COMPLETED WITH A INTELLAMAP ORION HIGH RESOLUTION MAPPING, INTELLANAV STABLEPOINT OPEN-IRRIGATED, AND DYNAMIC XT CATHETERS. HOWEVER POST PROCEDURE IT WAS NOTED THAT THE PATIENT EXPERIENCED A STROKE.
Patient problems: Ischemia Stroke
MAUDE report 11878253 ↗
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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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