Dynamic XT™ M0042011030Recalls & reported problems
Boston Scientific Corporation · Unidirectional Steerable Diagnostic Catheter · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729877639), received between Oct 30, 2019 and Aug 3, 2026 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
- Contamination1
- Defective Device1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50115122 ↗MalfunctionJul 27, 2020Defective Device; Defective Device
IT WAS REPORTED THAT THE TIP OF CATHETER WAS APART FROM SHAFT. BEFORE THE PROCEDURE A DYNAMIC XT ELECTRODE CATHETER WAS SELECTED FOR USE. IT WAS FOUND THAT THE TIP OF CATHETER WAS APART FROM SHAFT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT ANY PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10326134 ↗MalfunctionOct 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT CONTAMINANTS WERE FOUND INSIDE THE STERILE PACKAGING. FOLLOWING INSPECTION OF A DYNAMIC XT CATHETER PRIOR TO USE IN A PROCEDURE, PRESENCE OF "FILAMENTS OF SUSPECTED ORIGIN" WERE OBSERVED. " FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE SEAL. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9256380 ↗MalfunctionOct 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT CONTAMINANTS WERE FOUND INSIDE THE STERILE PACKAGING. FOLLOWING INSPECTION OF A DYNAMIC XT CATHETER PRIOR TO USE IN A PROCEDURE, PRESENCE OF "FILAMENTS OF SUSPECTED ORIGIN" WERE OBSERVED. " FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE SEAL. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9256378 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.