Dynamic XT™ M0046DYNXT0140Recalls & reported problems
Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729879923), received between Jun 18, 2020 and Jun 18, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A DYNAMIC XT CATHETER WAS FOUND TO HAVE FILAMENTS OF "SUSPECTED ORIGIN" ON THE CATHETER. THERE WAS NO PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10167721 ↗MalfunctionJun 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A DYNAMIC XT CATHETER WAS FOUND TO HAVE FILAMENTS OF "SUSPECTED ORIGIN" ON THE CATHETER. THERE WAS NO PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10167639 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.