Blazer Prime® HTD M004P5031THN40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729803607), received between Mar 5, 2019 and Jun 8, 2023 — classified as 2 malfunctions.

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

• MalfunctionJun 8, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE THAT DURING AN ABLATION PROCEDURE USING A BLAZER PRIME HTD THE TIP OF THE CATHETER FRACTURED. DURING FIRST USE OF THE CATHETER THE DEVICE FRACTURED TOWARDS THE TIP OF THE DEVICE AND SHARP METAL WAS EXPOSED. THEY EXCHANGED THE CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETERS IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086897 ↗
• MalfunctionMar 5, 2019Material Deformation; Temperature Problem; Material Deformation; Temperature Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON 25FEB2019. IT WAS REPORTED THAT THERE WAS A TEMPERATURE SENCING ISSUE AND A CATHETER KINK OCCURRED. A BLAZER PRIME CATHETER WAS SELECTED FOR A ABLATION PROCEDURE. UPON OPENING THE PACKAGE IT WAS NOTED THAT THE DISTAL TIP WAS BENT. IT WAS NOTICED THAT IMMEDIATELY UPON INITIATING RADIOFREQUENCY ABLATION THE GENERATOR REACHED MAX TEMP OF 50C. THE POWER NEVER GOT ABOVE 5W. THE MAESTRO 4000 GENERATOR WAS TESTED AFTER THE PROCEDURE AND NORMAL FUNCTION WAS CONFIRMED. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE DEVICE REVEALED FLUID INGRESS AND BROKEN ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390831 ↗

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 (