Blazer® II M0045031T0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729082811), received between Aug 22, 2017 and Jan 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Temperature Problem

  IT WAS REPORTED THAT THERE WAS NO CHANGE IN THE TEMPERATURE. A BLAZER II TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THERE WAS NO CHANGE IN THE TEMPERATURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO INFORMATION HAS BEEN PROVIDED AT THIS TIME REGARDING THE OUTCOME OF THE PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204635 ↗
• MalfunctionJun 27, 2024Temperature Problem; Temperature Problem

  THE BLAZER CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT THE TEMPERATURE COULDN'T EXCEED 40 DEGREES CELSIUS. REPLACING THE CATHETER RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624243 ↗
• MalfunctionNov 30, 2017Device Sensing Problem; Device Sensing Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22NOV2017 IT WAS REPORTED THAT HIGH TEMPERATURE READINGS OCCURRED. A BLAZER® II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT HIGH TEMPERATURE READINGS WAS ENCOUNTERED WHEN CONNECTED WITH THE MAESTRO 3000. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE ON THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070532 ↗
• MalfunctionAug 22, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A DIFFICULTY IN CATHETER REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED AT THE ATRIUM. A 110X2.5 BLAZER II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS UNABLE TO INSERT INSIDE THE CORONARY SINUS (CS). IT WAS ALSO OBSERVED THAT IN THE COURSE OF REMOVING THE DEVICE, A DIFFICULTY IN REMOVAL WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6809619 ↗

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 (