Blazer Prime® HTD M004P5031TH0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729803614), received between Mar 15, 2017 and Dec 6, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT WOLFF-PARKINSON-WHITE THE PATIENT'S MITRAL VALVE WAS DAMAGED. DURING THE PROCEDURE THERE WAS DIFFICULTY MOVING THE CATHETER THROUGH THE PATIENT'S ANATOMY. A CHORDA TENDINEAE RUPTURE OF THE MITRAL VALVE OCCURRED WHEN THEY ATTEMPTED TO FORCEFULLY REMOVE THE CATHETER. SURGERY WAS PERFORMED TO REPAIR THE DAMAGE AND A MITRAL VALVE REPLACEMENT WAS PERFORMED. THE PATIENT WAS HOSPITALIZED FOR THREE WEEKS FOLLOWING THE SURGERY. PER THE PHYSICIAN, THERE WAS NO ISSUE OR DEFECT WITH THE CATHETER. THE CATHETER HAD BEEN CAUGHT IN THE CHORDA TENDINEAE OF THE MITRAL VALVE DUE TO POSITIONING OF THE DEVICE DURING THE PROCEDURE. THE CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF AFTER THE PROCEDURE.

  Patient problems: Mitral Perforation

  MAUDE report 18275129 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAVOTRICUSPID ISTHMUS ABLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION A BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. THE CONNECTION BETWEEN THE CATHETER HANDLE AND SHAFT BROKE. THE PROCEDURE WAS COMPLETED USING THE SAME CATHETER. NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182216 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED TAMPONADE. A BLAZER PRIME® HTD WAS SELECTED TO BE USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A TAMPONADE AND PERICARDIOCENTESIS HAD TO BE PERFORMED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 6407768 ↗

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 (