Blazer® II HTD M0045031THN40Recalls & reported problems
Boston Scientific Corporation · Temperature Ablation Catheter · Class 3
All models of Blazer II HTD (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08714729172093), received between Dec 11, 2025 and Dec 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P920047); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Perforation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Material Perforation; Material Perforation
IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A BLAZER II HTD (HIGH TORQUE DISTAL) CATHETER WAS SELECTED FOR USE. UPON RECEIPT, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN, ALTHOUGH, THE PACKAGING SHOWED NO SIGNS OF PROBLEMS. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785397 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P920047. One submission often covers many models, so check the product and lot details in each record.
- Z-0202-2019 · Jun 20, 2018 · Open, ClassifiedBoston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
- Z-0973-2011 · Jul 14, 2009 · TerminatedRF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000
- Z-1617-2008 · Feb 14, 2008 · TerminatedBoston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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