Blazer® II HTD M0045031TH0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729172048), received between Apr 18, 2017 and Feb 21, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (7 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 15, 2017Radio Signal Problem; Radio Signal Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-AUG-2017. IT WAS REPORTED THAT NO CATHETER SIGNAL OCCURRED. A 7/110/2.5/7-4 QUAD BLAZER® II HTD WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTICED THAT THE SIGNAL WAS NOT VISIBLE. FURTHERMORE, THE RECORDING EQUIPMENT SETTINGS AND CABLE WERE CHANGED BUT THE SIGNAL IS STILL NOT VISIBLE. FINALLY, THE CATHETER WAS CHANGED WITH ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE RING 1 SEAL IS COMPROMISED AND THERE IS BODY FLUID ON THE EDGES OF THE RING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868398 ↗
• MalfunctionJul 28, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-JUL-2017. IT WAS REPORTED THAT DEVICE STEERING MECHANISM WAS BROKEN. A7/110/2.5/7-4 QUAD BLAZER® II HTD WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE DEVICE HAD A BROKEN DEFLECTION MECHANISM. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SEAL ON THE TORQUE HOLE APPEARS TO HAVE BEEN COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 6751009 ↗
• MalfunctionMay 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15MAY2017. IT WAS REPORTED THAT THE DEVICE HAS NO SIGNAL, DID NOT ABLATE AND THE POWER DID NOT RISE. A 7/110/2.5/7-4 QUAD K1 BLAZER® II WAS SELECTED FOR USE. DURING THE PROCEDURE AFTER THE CATHETER WAS POSITIONED, IT WAS NOTICED THAT THERE WAS NO SIGNAL, THE POWER DID NOT RISE AND WAS UNABLE TO ABLATE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALS THAT A YELLOW-ORANGE SUBSTANCE UNDER THE PROXIMAL SEAL OF RING 3 WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6602979 ↗
• MalfunctionApr 18, 2017Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-APR-2017. IT WAS REPORTED THAT NO SIGNAL ON THE RECORDING SYSTEM OCCURRED AND THE STEERING MECHANISM WAS BROKEN. A 7FR/4 MM BLAZER® II HTD WAS SELECTED FOR USE. DURING PROCEDURE WHEN THE PHYSICIAN USED THE DEVICE FOR MAPPING, IT WAS NOTICED THAT THE CATHETER'S SIGNAL WAS NOT VISIBLE ON THE RECORDING SYSTEM. FURTHERMORE, THE CATHETER CABLE WAS REPLACED; HOWEVER, THE SAME ISSUE OCCURRED. THE CATHETER WAS THEN REMOVED AND REPLACED WITH ANOTHER OF THE SAME CATHETER AND THE SIGNAL WAS VISIBLE AGAIN ON THE RECORDING SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE RING 2 AND RING 3 SEALS WERE COMPROMISED WITH BODY FLUIDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499650 ↗

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, Classified
  Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
• Z-0973-2011 · Jul 14, 2009 · Terminated
  RF 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 · Terminated
  Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (