Blazer® II M0045031TK10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729082439), received between Jul 12, 2019 and Aug 23, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Failure to Deliver Energy; Defective Device; Failure to Deliver Energy; Defective Device

  IT WAS REPORTED THAT DURING A CARDIAC RADIOFREQUENCY ABLATION, A BLAZER II CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, ABLATION THE DISCHARGE WAS ABNORMAL, AND THE ADJUSTMENT OF THE TAIL LINE COULD NOT BE SOLVED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THIS CATHETER IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276427 ↗
• InjuryJul 12, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO WITHDRAW. DURING AN ABLATION PROCEDURE FOR WOLFF-PARKINSON-WHITE (WPW) SYNDROME, ABLATION WAS PERFORMED OF THE LEFT ATRIUM MITRAL VALVE ANNULUS WITH A BLAZER II CATHETER. THE PROCEDURE WAS STARTED BY APPROACHING FROM THE AORTA. WHEN THE CATHETER WAS REMOVED FROM THE LEFT ATRIUM AFTER COMPLETING THE ABLATION, THE TIP OF THE CATHETER WAS TANGLED WITH THE A VALVE CHORD AND IT BECAME UNABLE TO REMOVE. THE CATHETER WAS PLANNED TO BE REMOVED BY SURGICAL THORACOTOMY. WITH REGARDS TO CATHETER REMOVAL SURGICALLY, THE CATHETER COULD NOT BE REMOVED FROM THE "AO SIDE", BUT THE CATHETER COULD BE REMOVED BY PULLING IT OUT FROM THE VENTRICULAR SIDE. IT WAS ALSO REPORTED THAT THE DEVICE "REMAINED INSIDE" THE PATIENT. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS "STILL ALIVE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8784341 ↗

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 (