Blazer™ Dx-20 M00420SL28600Recalls & reported problems
Boston Scientific Corporation · Bidirectional Steerable Diagnostic Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729780533), received between Apr 11, 2018 and Mar 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
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
Device problems
- Electrical /Electronic Property Problem1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
REPORTABLE BASED ON ANALYSIS COMPLETED ON 03 MAR 2021. IT WAS REPORTED THAT DURING PREPARATION OF A BLAZER DX-20 THE ELECTRODE DID NOT WORK. THE PROCEDURE WAS COMPLETED BY EXCHANGING THE CATHETER. HOWEVER ANALYSIS REVEALED CATHETER SHAFT DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11542750 ↗MalfunctionApr 11, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THE CATHETER BECAME ENTANGLED IN THE PATIENT¿S ANATOMY. A BLAZER¿ DX ABLATION CATHETER WAS SELECTED FOR USE IN AN ATRIAL FIBRILLATION ABLATION PROCEDURE. THE CATHETER WAS INTRODUCED INTO THE FEMORAL VEIN AND WAS BEING PUSHED UP INTO THE HEART WHEN IT PROLAPSED ON ITSELF AND THEN BECAME ENTANGLED IN THE TRICUSPID VALVE. THE PHYSICIAN WORKED TO UNTANGLE THE CATHETER FROM THE TISSUE AND THE STEERING MECHANISM STOPPED WORKING. THE PHYSICIAN INTRODUCED A SNARE TO DISLODGE THE CATHETER FROM THE TRICUSPID VALVE. THE CATHETER WAS REMOVED AND ANOTHER MANUFACTURER¿S CATHETER WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7421251 ↗
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- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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