Blazer® II XP M0044790THK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729452386), received between Dec 20, 2016 and Dec 20, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Charred” (2 reports).

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 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.

• MalfunctionDec 20, 2016Charred; Device Operates Differently Than Expected; Charred; Device Operates Differently Than Expected

  SAME CASE AS MDR ID 2134265-2016-11316. IT WAS REPORTED THAT THERE WAS CHAR ON THE DEVICE, AND STEAM POPS OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAVOTRICUSPID ISTHMUS(CTI). A BLAZER® II XP WAS SELECTED FOR USE. ON THE MIDDLE OF A FLUTTER ABLATION, IT WAS NOTED THAT THE FIRST TWO CATHETER USED SEEMED TO BE NOT ABLATING SUFFICIENTLY AND PROPERLY. IN ADDITION, STEAM POPS WERE HEARD AND THE EXPECTED REDUCTION IN ELECTROGRAM AMPLITUDE DURING SUCCESSFUL TISSUE ABLATION WAS NOT OBSERVED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT'S BODY; HOWEVER, A CHAR ON THE PROXIMAL EDGE OF THE DISTAL ELECTRODES WERE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190818 ↗
• MalfunctionDec 20, 2016Charred; Device Operates Differently Than Expected; Charred; Device Operates Differently Than Expected

  SAME CASE AS MDR ID 2134265-2016-11315. IT WAS REPORTED THAT THERE WAS CHAR ON THE DEVICE, AND STEAM POPS OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAVOTRICUSPID ISTHMUS(CTI). A BLAZER® II XP WAS SELECTED FOR USE. ON THE MIDDLE OF A FLUTTER ABLATION, IT WAS NOTED THAT THE FIRST TWO CATHETER USED SEEMED TO BE NOT ABLATING SUFFICIENTLY AND PROPERLY. IN ADDITION, STEAM POPS WERE HEARD AND THE EXPECTED REDUCTION IN ELECTROGRAM AMPLITUDE DURING SUCCESSFUL TISSUE ABLATION WAS NOT OBSERVED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT'S BODY; HOWEVER, A CHAR ON THE PROXIMAL EDGE OF THE DISTAL ELECTRODES WERE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190804 ↗

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,