Blazer™ Dx-20 M00420SL21020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729780526), received between Jun 12, 2019 and Nov 5, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. A BLAZER DX-20 CATHETER WAS USED DURING AN ATRIAL FIBRILLATION (AF) PROCEDURE. DURING THE PROCEDURE, A NON-SUSTAINED ATRIAL TACHYCARDIA WAS OBSERVED IN THE LATERAL WALL OF THE RIGHT ATRIUM. AN INTELLAMAP ORION CATHETER WAS UTILIZED TO MAP THE PATIENT'S CARDIAC ACTIVITY. THE PHYSICIAN SUSPECTS THAT THE DIAGNOSTIC CATHETER MAY HAVE PUSHED TOO HARD CAUSING A SMALL PERFORATION NEAR THE TIP OF THE LATERAL ANNULUS DURING THE TACHYCARDIA EPISODE. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED, AS THE PHYSICIAN IS CONFIDENT THAT THE COMPLICATION WILL RESOLVE SPONTANEOUSLY. THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, THE ABLATION WORKFLOW WAS NORMAL AND NOT PROLONGED. THE PATIENT REMAINS ADMITTED FOR MONITORING AND IS EXPECTED TO RECOVER. THE NEXT DAY, THE PATIENT WAS DISCHARGED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF BY THE FACILITY.

  Patient problems: Cardiac Perforation; Pericardial Effusion; Tachycardia

  MAUDE report 23476668 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INTERRUPT AF CLINICAL STUDY, CLINICAL STUDY ID: (B)(4), SUBJECT ID: (B)(4). IT WAS REPORTED THAT DURING A ABLATION PROCEDURE INVOLVING AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, BLAZER DX-20 DIAGNOSTIC CATHETER AND A INTELLANAV MIFI O WERE SELECTED FOR USE. AFTER PULMONARY VEIN ISOLATIONS, BLOOD PRESSURE DECREASED AND INCREASED PRESSOR SUPPORT WAS REQUIRED. A LARGE PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING. EMERGENT PERICARDIOCENTESIS WAS PERFORMED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 16632048 ↗
• MalfunctionNov 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING PREPARATION OF A RIGHT ATRIAL FLUTTER PROCEDURE, A BLAZER DX CATHETER WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, SOMETHING BLACK WAS OBSERVED BEHIND THE STEERABLE BI-WING KNOB. AN EXCHANGE OF THE CATHETER RESOLVED THE ISSUE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809413 ↗
• MalfunctionSep 10, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TECHNICIAN WAS OPENING THE BOX FOR THE BLAZER DX-20, AND NOTICED A TEAR IN THE PLASTIC PACKAGING PROTECTING THE STERILE CATHETER. THIS CATHETER WAS NOT USED, AND NEW ONE WAS PULLED OUT TO USE. THE PACKAGING WAS FINE ON THE SECOND CATHETER, AND IT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453067 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEWTON AF CLINICAL STUDY: IT WAS REPORTED THAT A BLAZER DX-20 WAS USED IN AN ATRIAL FIBRILLATION ABLATION PROCEDURE. AFTER THE PROCEDURE THE PATIENT EXPERIENCED CHEST TIGHTNESS THAT EXTENDS UP TO THEIR THROAT AT TIMES AND MAKES IT HARD TO BREATH WHICH BECAME WORSE AT NIGHT. THE PATIENT WAS GIVEN COLCHICINE AND HAD STAT ECHOCARDIOGRAM.

  Patient problems: Chest Pain

  MAUDE report 12233997 ↗
• InjuryApr 28, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT), IN THE PROCESS OF APPROACHING THE BLAZER DX CATHETER TO THE CORONARY SINUS (CS) OSTIUM, THE CATHETER "WAS NOT CURVED." THE CATHETER DIDN'T MOVE AT THE TRICUSPID VALVE (TV) MUSCLE DUE TO IT BEING UNABLE TO CURVE FOR CS APPROACH. THE CURVE WAS JAMMED OR UNABLE TO BE STRAIGHTENED. THE CATHETER WAS "STUCK" AT THE MUSCLE AND WOULD NOT MOVE. THE PHYSICIAN TRIED MANY TIMES TO EXTRACT THE DEVICE, BUT WAS UNABLE TO. THEREFORE, THE PHYSICIAN NEEDED TO USE A TRIO SHEATH CONNECTOR TO EXTRACT THE BLAZER DX CATHETER FROM THE MUSCLE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER DEVICE. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741321 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THE PATIENT EXPERIENCED ACUTE DIASTOLIC CONGESTIVE HEART FAILURE (CHF). THREE DAYS FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER, A BLAZER DX-20 AND AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, THE PATIENT WENT TO THE HOSPITAL FOR SHORTNESS OF BREATH ON EXERTION AND WEAKNESS. THE SUSPECTED CAUSE WAS ACUTE DIASTOLIC CONGESTIVE HEART FAILURE. LASIX WAS ADDED TO THE PATIENT'S ORAL MEDICATION TREATMENT AND THE EVENT RESOLVED.

  Patient problems: Congestive Heart Failure; Dyspnea; Weakness

  MAUDE report 10046568 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. AN ABLATION PROCEDURE WAS COMPLETED USING AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER, AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, A BLAZER DX-20 CATHETER, A NON-BOSTON SCIENTIFIC DIAGNOSTIC CATHETER AND FOUR NON-BOSTON SCIENTIFIC SHEATHS. ON (B)(6) 2019, THE PATIENT PRESENTED TO OUTSIDE HOSPITAL WITH CHEST PAIN WHICH DID NOT RESPOND TO NITROGLYCERIN. AN ECHOCARDIOGRAM WAS COMPLETED WHICH DID NOT SHOW AN EFFUSION. THE PATIENT WAS MONITORED OVERNIGHT AND DISCHARGED WITH COLCRYS FOR PAIN MANAGEMENT. THE SUSPECTED CAUSE WAS MILD PERICARDITIS. THE EVENT RESOLVED ON (B)(6) 2020.

  Patient problems: Chest Pain

  MAUDE report 9701288 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION. DURING AN ABLATION PROCEDURE FOR ATRIAL FLUTTER, A BLAZER DX-20 CATHETER WAS INSERTED IN THE PATIENT WITH NO ISSUES. THEN, AN INTELLAMAP ORION CATHETER WAS INSERTED INTO THE PATIENT WITH NO ISSUES. ABOUT 5 MINUTES LATER, THE PATIENT'S BLOOD PRESSURE DROPPED. THEY HAD TO DO COMPRESSIONS AND THEN THE PATIENT'S PRESSURE WAS FINE. THE CASE WAS THEN CANCELLED. THE DOCTOR CHECKED WITH ULTRASOUND TO CHECK IF THERE WAS AN EFFUSION FROM THE CATHETERS AND THERE WAS NOT. THE PHYSICIAN BELIEVED THAT THE EVENT WAS DUE AN ANESTHESIA ISSUE AND NOT THE DEVICES. THE PATIENT WAS FINE AND THERE WERE NO OTHER COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE "COMPRESSIONS" MEANT THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR).

  Patient problems: Cardiopulmonary Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 8691221 ↗