Blazer II HTDRecalls & reported problems across all models

We found 4 models of Blazer II HTD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Mar 30, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Blazer II HTD problems

Blazer II HTD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Blazer® II HTD M0045031TH0

  Cardiac ablation percutaneous catheter
  14 reports
• Blazer® II HTD M0045031THK20

  Cardiac ablation percutaneous catheter
  7 reports
• Blazer® II HTD M0045031THN40

  Cardiac ablation percutaneous catheter
  1 report
• Blazer® II HTD M0045086THK20

  Cardiac ablation percutaneous catheter
  1 report

Recent Blazer II HTD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Perforation

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. DURING A PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT), A BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS USED. IT WAS OBSERVED THAT THE CATHETER WAS FRACTURED. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709244 ↗
• 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 ↗
• MalfunctionNov 28, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE ENERGY DID NOT INCREASE. A BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THE ENERGY DID NOT INCREASE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE HAS BEEN RECEIVED AND ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672102 ↗
• MalfunctionMar 6, 2024Temperature Problem; Temperature Problem

  THE BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT THE TEMPERATURE WOULD FLUCTUATE MULTIPLE TIMES. AFTER THE TEMPERATURE ROSE ABOVE 70 DEGREES, THEY SLOWLY TURNED IT ON, BUT THE POWER WAS FIXED AT 10WATT AND THEY DID NOT SEE ANY RISE. A DIFFERENT DEVICE WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXCEPTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849398 ↗
• MalfunctionFeb 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE BLAZER TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE DURING THE ABLATION PROCEDURE. IT WAS REPORTED THAT FOREIGN SUBSTANCE WAS OBSERVED IN THE CATHETER HANDLE. THE DEVICE WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751614 ↗
• MalfunctionNov 27, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE USING A BLAZER II HTD TEMPERATURE ABLATION CATHETER A "TEMPERATURE ERROR" OCCURRED. THEY EXCHANGED THE CATHETER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212414 ↗
• MalfunctionJul 26, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA A BLAZER II HTD CATHETER WAS SELECTED FOR USE, HOWEVER, THE DEVICE PRESENTED AN ISSUE RELATED TO ITS SENSOR AND A TEMPERATURE ERROR, THEREFORE IT WAS DECIDED TO REPLACE THE DEVICE AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397398 ↗
• MalfunctionJul 6, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A BLAZER II HTD CATHETER A TEMPERATURE ERROR OCCURRED. THEY EXCHANGED THE CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268266 ↗
• MalfunctionMar 20, 2023Temperature Problem; Temperature Problem

  DURING A PSVT PROCEDURE A BLAZER CATHETER WAS SELECTED FOR USE. A TEMPERATURE ERROR OCCURRED. AN EXCHANGE OF THE CATHETER RESOLVED THE PROBLEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574123 ↗
• MalfunctionMar 17, 2022Output Problem; Temperature Problem; Output Problem; Temperature Problem

  DURING AN ABLATION PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, A BLAZER II HTD CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE POWER DID NOT INCREASE DURING PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794689 ↗
• MalfunctionFeb 10, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON JANUARY 12, 2022. DURING A PROCEDURE TO TREAT TACHYCARDIA A BLAZER II HTD CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THERE WAS NO ELECTRIC POTENTIAL AFTER THE CATHETER ENTERED BODY. CATHETER CONNECTION WAS NORMAL. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A CIRCULAR CUT IN THE DISTAL SECTION OVER THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508374 ↗
• InjuryOct 7, 2021Temperature Problem; Temperature Problem

  DURING AN ABLATION PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA A BLAZER II HTD CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE DID NOT MEET THE ABLATION REQUIREMENTS OF THE LESION. REPEATED ABLATION ATTEMPTS RESULTED IN EDEMA ON THE CONTACT SURFACE OF THE LESION. "EMERGENCY TREATMENT" MIGHT HAVE BEEN PERFORMED TO TREAT THE EDEMA, HOWEVER THE DETAILS ARE UNKNOWN. THE PROCEDURE WAS CANCELLED AND RESCHEDULED. NO ADDITIONAL COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

  Patient problems: Swelling/ Edema

  MAUDE report 12590986 ↗
• MalfunctionJun 3, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A BLAZER II HTD CATHETER TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA [PSVT] THE DISPLAYED TEMPERATURE DID NOT INCREASE DURING ABLATION. THEY FIRST REPLACED THE CABLE, HOWEVER, THE ISSUE WAS NOT RESOLVED. THEY THEN REPLACED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935357 ↗
• MalfunctionMar 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE BLAZER II CATHETER WAS RECEIVED AND INSPECTED, IT WAS NOTED THAT THERE WAS A PROBLEM WITH THE LABELED UPN IN CHINESE. THE UPN FROM FACTORY IS M0045031TH0 BUT THE UPN ON CHINESE LABEL IS M0044500TH0. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE HAS BEEN RETURNED TO BOSTON SCIENTIFIC AND ANALYSIS HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556182 ↗
• MalfunctionOct 14, 2020Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A BLAZER II HTD WAS USED IN A ATRIAL FIBRILLATION (AF) RADIOFREQUENCY ABLATION PROCEDURE. WHEN THE CATHETER WAS INTRODUCED INTO THE THERE WAS NO TEMPERATURE PERCEPTION. IT WAS ALSO REPORTED THAT NO ERROR MESSAGES WERE DISPLAYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678254 ↗

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