Blazer Prime® XP M004P4790THN40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729802372), received between Aug 11, 2020 and Nov 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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.

• MalfunctionNov 29, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE USING A BLAZER PRIME XP CATHETER TO TREAT ATRIAL FIBRILLATION THE TIP OF THE CATHETER TIP BECAME DEFORMED AND UNABLE TO BE STRAIGHTENED. THE ISSUE AROSE APPROXIMATELY AN HOUR INTO THE PROCEDURE. THEY EXCHANGED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885341 ↗
• MalfunctionAug 11, 2020Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT A BLAZER PRIME XP WAS USED IN AN ABLATION PROCEDURE, IT WAS NOTED DURING THE PROCEDURE THAT THE PHYSICIAN DID NOT FEEL THE TIP OF THE CATHETER CAME INTO CONTACT WITH TISSUE DURING ENERGIZATION. THE CATHETER WAS REMOVED AND WAS NOTED TO HAVE THE DISTAL END TWISTED WITH A WIRE PERFORATING THE INSOLATION PROXIMAL THE FIRST RING ELECTRODE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390628 ↗

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,