Blazer™ Dx-20 M00420SL5550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729780496), received between May 24, 2018 and Aug 26, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ABLATION PROCEDURE, A BLAZER DX-20 DIAGNOSTIC CATHETER WAS SELECTED FOR USE. THE LAB STAFF FOUND A HOLE IN ONE OF THE CATHETER PACKAGES PRIOR TO BEING OPENED. THE HOLE WAS IN THE STERILE PACKAGING BY THE HANDLE OF THE CATHETER. PRODUCT WAS NOT USED DURING THE PROCEDURE. A NEW NON-DAMAGED CATHETER WAS USED TO COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE WAS RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066127 ↗
• MalfunctionDec 16, 2023Difficult to Remove; Positioning Problem; Physical Resistance/Sticking; Difficult to Remove; Positioning Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE THE CATHETER DEFLECTION ISSUES OCCURRED AND COULD NOT BE RETRACTED RIGHT AWAY. THE CATHETER WAS INSERTED THROUGH THE FRENCH PINNACLE SHEATH, AND ADVANCED INTO THE HEART FROM THE RIGHT FEMORAL VEIN ACCESS. UNDER FLUOROSCOPY IT WAS SEEN THAT THE CATHETER WAS RETROFLEXED, AND THEY ATTEMPTED TO MANIPULATE MECHANISM, ADVANCE, AND RETRACT SVC BACK INTO THE FEMORAL LANE, BUT THE CATHETER DID NOT RETURN TO STRAIGHT. CATHETER WAS THROUGH THE SHEATH. THE CATHETER STAYED STUCK AND COULD NOT BE WITHDRAWN AT FIRST. THEY ADVANCED INTO THE HEART AND PULLED BACK INTO THE FEMORAL VEIN BUT DID NOT IMPROVE THE STATE. THEN, WITH MUCH EFFORT, THE CATHETER WAS SUCCESSFULLY RETRACTED AND REMOVED FROM THE BODY THROUGH THE 10F SHEATH. NO PATIENT COMPLICATIONS OCCURRED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CATHETER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341625 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A BLAZER¿ DX-20 DIAGNOSTIC CATHETER WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE. A QUAD CATHETER, INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER, ABLATION CATHETER, TWO SHEATHS, AND A TRANSSEPTAL NEEDLE FROM OTHER MANUFACTURERS WERE ALSO SELECTED FOR USE. THE QUAD CATHETER WAS PLACED IN THE RIGHT VENTRICLE, AND THE BLAZER DX-20 CATHETER WAS PLACED IN THE RIGHT ATRIUM WITH THE DISTAL PORTION IN THE CORONARY SINUS. THE ICE CATHETER WAS ALSO PLACED IN THE RIGHT ATRIUM. A SHEATH AND NEEDLE WERE USED FOR TRANSSEPTAL ACCESS; DUE TO THE PATIENT¿S ROTATED ANATOMY AND LOW FOSSA OVALIS, THE PHYSICIAN HAD DIFFICULTY GAINING ACCESS TO THE LEFT ATRIUM (LA). LA ACCESS WAS GAINED; THE ABLATION CATHETER WAS INSERTED THROUGH THE SHEATH AND SOME LA ANATOMY WAS CREATED. THE SHEATH WAS EXCHANGED FOR A SHEATH FROM A DIFFERENT MANUFACTURER, WHEN A DROP IN BLOOD PRESSURE WAS NOTICED AND A PERICARDIAL EFFUSION WAS OBSERVED BY THE ICE CATHETER. A PERICARDIAL DRAIN WAS PLACED. ALL CATHETERS WERE THEN REMOVED FROM THE HEART. MINIMAL EFFUSION WAS EVIDENT WHEN THE PATIENT LEFT THE ROOM IN STABLE CONDITION. THE PHYSICIAN

  Patient problems: Pericardial Effusion

  MAUDE report 7540592 ↗