BRK™ 407206Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734205122), received between Jun 22, 2018 and Jan 5, 2026 — classified as 2 deaths, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fluid/Blood Leak

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE NEEDLE LEAKED CONTRAST AGENT FLUID AT THE INJECTION SITE. A SLIP-TIP SYRINGE WAS USED. THE NEEDLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970863 ↗
• DeathOct 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MITRACLIP PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND EXPIRED. THE PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+. A TRICLIP STEERABLE GUIDE CATHETER (TSGC) WAS USED OFF-LABEL WITH THE MITRACLIP CLIP DELIVERY SYSTEM (CDS) AS IT WAS ALSO PLANNED TO TREAT TRICUSPID REGURGITATION (TR) GRADE 3-4 AFTER THE MR. PATIENT WAS FRAIL BUT STABLE. INITIAL STEERING TO THE MITRAL VALVE WAS DIFFICULT DUE TO PROMINENT COUMADIN RIDGE. DURING INITIAL STEERING TO THE MITRAL VALVE A DROP OF BLOOD PRESSURE WAS NOTICED AND ECHOCARDIOGRAPHER CONFIRMED CIRCUMFERENTIAL PERICARDIAL EFFUSION. LOCATION WAS UNKNOWN AS BLEEDING SPREAD QUICKLY. PHYSICIAN CONCLUDED CARDIAC TAMPONADE WAS PRESENT. PROTAMINE ADMINISTERED. PATIENT TURNED HEMODYNAMICALLY UNSTABLE. PERICARDIOCENTESIS WAS PERFORMED AS THE TSGC AND CDS WERE REMOVED. PERICARDIOCENTESIS WAS UNSUCCESSFUL AND THE PATIENT'S CONDITION WORSENED. DUE TO THIS, OPEN HEART SURGERY WAS PERFORMED. AFTER INITIAL IMPROVEMENT WITH ECMO, THE PATIENT'S CONDITION DIMINISHED AND COULD NOT BE STABILIZED. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO RESUSCITATE THE PATIENT DIED. IT WAS THOUGHT THE PERICARDIAL EFFUSION WAS DUE

  Patient problems: Cardiac Perforation

  MAUDE report 23388095 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED PERICARDIOCENTESIS. DURING RIGHT VENTRICLE MAPPING, PATIENT RHYTHM CHANGED TO VENTRICULAR TACHYCARDIA AND AN ELECTRICAL SHOCK WAS DELIVERED. THE SYSTEM THEN STATED THAT THE POSTERIOR PATIENT REFERENCE SENSOR POSITION HAD CHANGED. THE CATHETERS WERE VISUALIZED; HOWEVER, A NEW MAP COULD NOT BE RECORDED. THE PATIENT REFERENCES SENSORS COULD NOT BE MOVED BACK TO THEIR ORIGINAL POSITION, SO THE "SET" BUTTON WAS UTILIZED WHICH REQUIRED RE-MAPPING. THE TRANSSEPTAL PUNCTURE WAS RE-DONE AND THE LEFT VENTRICLE WAS REMAPPED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING THE NIGHT, AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGED THAT THE SECOND TRANSSEPTAL PUNCTURE CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 17239175 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TRANSSEPTAL PUNCTURE, A CARDIAC PERFORATION OCCURRED WITH NO INTERVENTION NEEDED. DURING THE PROCEDURE, THE PHYSICIAN PUNCTURED THE EPICARDIUM WITH THE TRANSSEPTAL NEEDLE, WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. THE PHYSICIAN WITHDREW THE NEEDLE AND STOPPED THE EXAMINATION. THE PATIENT REMAINED STABLE AND WAS MOVED TO THE OBSERVATION STATION WITH NO CONSEQUENCES.

  Patient problems: Cardiac Perforation

  MAUDE report 17130687 ↗
• DeathOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION AND ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT DECOMPENSATED AND LIFE SAVING MEASURES WERE TAKEN. AFTER TWO HOURS OF RESUSCITATION, THE PATIENT PASSED AWAY. WHEN DRAWING BLOOD FOR ACT CHECKS AFTER TRANSSEPTAL PUNCTURE, BLOOD APPEARED DARKER AND THE PATIENT'S VITAL SIGNS BEGAN WORSENING. AN ECHOCARDIOGRAM WAS PERFORMED AND A PERICARDIAL EFFUSION WAS DIAGNOSED. THE EFFUSION WAS GROWING RAPIDLY, AND A PERICARDIOCENTESIS WAS PERFORMED TWICE. IT IS BELIEVED THE DEATH WAS DUE TO THE PERICARDIAL EFFUSION, HOWEVER, THE CAUSE OF DEATH WAS NOT CONFIRMED AS NO AUTOPSY WAS PERFORMED. THERE IS NO ALLEGED DEVICE MALFUNCTION.

  Patient problems: Cardiac Perforation

  MAUDE report 12598825 ↗
• MalfunctionNov 19, 2020Flaked; Flaked

  DURING AN ATRIAL FIBRILLATION PROCEDURE, SKIVING WAS NOTED. DURING TRANSSEPTAL PUNCTURE, PRESSURE AT THE TIP OF THE NEEDLE WAS NO LONGER VISIBLE. THE NEEDLE WAS THEN PULLED BACK, AND A SMALL PIECE OF PLASTIC WAS VISIBLE AT THE TIP OF THE NEEDLE. THE NEEDLE WAS REPLACED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10868866 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. FOLLOWING TRANSSEPTAL ACCESS AND CREATION OF THE LEFT ATRIAL MODEL THE PATIENT BECAME HYPOTENSIVE. INTRACARDIAC ECHOGRAPHY CONFIRMED A 1CM PERICARDIAL EFFUSION. ALL CATHETERS WERE REMOVED FROM THE PATIENT AND PROTAMINE WAS ADMINISTERED TO REVERSE THE BLOOD THINNING. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE OF THE REPORTED PERFORATION WAS DURING TRANSSEPTAL ACCESS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7741459 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING NUMBER: 2182269-2018-00080, 3008452825-2018-00195, 9680001-2018-00084, 3005334138-2018-00174, 008452825-2018-00194, 3008452825-2018-00198. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN ELDERLY PATIENT WHO WAS VERY PRO-ARRHYTHMIC DURING THE VT PROCEDURE, WITH A SYSTOLIC BLOOD PRESSURE (SBP) OF 100 FROM THE INITIATION OF THE PROCEDURE. WHILE THE TACTICATH WAS BEING MANIPULATED IN THE VENTRICLE, THE PATIENT'S SBP DECREASED TO 85-90, THE PROCEDURE WAS PAUSED AND AFTER 30 MINUTES THE BP REMAINED LOW AN ECHOCARDIOGRAM REVEALED A SMALL PERICARDIAL EFFUSION. WHILE PREPPING TO PERFORM A PERICARDIOCENTESIS THE PATIENT'S BP DROPPED AND THE PATIENT DECOMPENSATED. A CATHETER WAS INTRODUCED INTO THE CORONARY SINUS FOR PACING AND A PERICARDIOCENTESIS AND BLOOD TRANSFUSION WERE PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7630691 ↗