Blazer® Open-Irrigated M00496200Recalls & reported problems
Boston Scientific Corporation · Ablation Catheter · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729862222), received between Jun 14, 2022 and Jun 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
1 other recall cover devices cleared under the same FDA submission (P150005); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Low Blood Pressure/ Hypotension1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE BLAZER OI CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB). IT WAS REPORTED THE PATIENT'S BLOOD PRESSURE TEMPORARILY DECREASED JUST BEFORE THE PROCEDURE WAS COMPLETED. THE PATIENT RECEIVED TEMPORARY PACING DUE TO THE EVENT. NO DEVICE ISSUE OCCURRED. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 19513652 ↗MalfunctionJun 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT LAB STAFF NOTICED AN UNKNOWN BLACK SUBSTANCE ALONG THE EDGE OF THE CONTROL KNOB OF A BLAZER OPEN-IRRIGATED CATHETER WHILE IN THE BOX. NO PATIENT OR PROCEDURE INVOLVED. DEVICE WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14690696 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P150005. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2019 · Nov 28, 2018 · Open, ClassifiedBlazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, ar
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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