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Blazer Open-Irrigated Ablation Catheter

by Boston Scientific

PMA P150005

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P150005↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP150005 Date24 Feb 2016ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0699-2019 FDA Class III initiated 28 Nov 2018

    Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
FDA applicant
Boston Scientific Corp
PMA Number
FDA Product Code
OAD
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Blazer Open-Irrigated Ablation Catheter is a percutaneous cardiac ablation catheter designed for electrophysiological mapping, diagnostic pacing, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL). Classified as a Class III device, it delivers precise energy to target cardiac tissue while maintaining irrigation to reduce thermal damage and improve procedural safety.

This device is intended for use with a Maestro 4000 Radiofrequency Controller and MetriQ Irrigation Pump, requiring sterile handling and single-use per manufacturer specifications. It is regulated under an FDA Premarket Approval (PMA) and is supplied in various model configurations, each identified by unique reference codes. Storage and handling must comply with sterile medical device protocols to ensure efficacy and patient safety.

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