Blazer® II XP M0044500TH0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729452270), received between Mar 1, 2017 and Mar 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P020025); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2017Temperature Problem; Temperature Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-FEB-2017. IT WAS REPORTED THAT THE POOR TEMPERATURE CONTROL OCCURRED. A BLAZER® II XP WAS SELECTED FOR USE. DURING PROCEDURE, THE GENERATOR WOULD GIVE A "TEMP OUT OF RANGE" ERROR AS THE TEMPERATURE WOULD ONLY REACH 46 DEGREE CELSIUS. THE CABLE WAS REPLACED BUT THE SAME RESULTS WOULD OCCUR. THE GENERATOR WAS RESET; HOWEVER, STILL THE SAME ISSUE PERSISTED. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED BLAZER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT ALL THREE RING SEALS ARE COMPROMISED AS THERE WERE DRIED BODY FLUID ALONG THE EDGES OF THE RINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6367919 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020025. 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,