BRKRecalls & reported problems across all models

We found 4 models of BRK by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Aug 14, 2026 — classified as 11 deaths, 129 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BRK problems

BRK models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BRK™ G407208

  Trocar
  3 deaths75 reports
• BRK™ 407200

  Trocar
  4 deaths71 reports
• BRK™ G407211

  Trocar
  2 deaths23 reports
• BRK™ 407206

  Trocar
  2 deaths8 reports

Recent BRK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  In the Chinese literature review, one publication ¿Acute cardiac tamponade caused by misperforation of the aorta during transseptal puncture without thoracotomy¿a case report¿ states that:A 65-year-old male patient underwent an electrophysiological study. After placement of a coronary sinus (CS) mapping catheter and a right ventricular mapping catheter, tachycardia was induced. During tachycardia, the atrial electrogram at CS7-8 preceded activation, and ventricular stimulation delivered during the His refractory period advanced atrial activation, suggesting the presence of a left-sided accessory pathway.Following the first transseptal puncture (TSP), an ST ablation catheter (Biosense Webster) was advanced into the left atrium. Under the guidance of the CARTO 3 mapping system, ventricular pacing near the mitral annulus adjacent to CS7-8 demonstrated the earliest atrial activation. Radiofrequency energy was delivered at 30 W for 10 seconds; however, the tachycardia did not terminate. The ablation catheter was then withdrawn into the right atrium, and no satisfactory target site was identified along either the tricuspid annulus or within the coronary venous system.A second TSP was sub

  Patient problems: Cardiac Tamponade; Great Vessel Perforation

  MAUDE report 50258481 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  During an atrial fibrillation procedure, a pericardial effusion was noticed after the transesophageal ultrasound. Drainage was not required and ablation was not performed due to the patient's particular anatomy and scoliosis. The pericardial effusion was pre-existing. However, the physician alleges that tenting on the aorta may have caused the pericardial effusion with the BRK needle.

  Patient problems: Cardiac Perforation

  MAUDE report 50228653 ↗
• MalfunctionJun 23, 2026Difficult to Insert; Improper or Incorrect Procedure or Method

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS DIFFICULTY INSERTING THE NEEDLE INTO THE PATIENT RESULTING IN A CANCELLATION OF PROCEDURE. DESPITE MULTIPLE ATTEMPTS, THE NEEDLE COULD NOT COMPLETE TRANSSEPTAL PUNCTURE FOR ACCESS. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE STYLET WAS USED, BUT THE NEEDLE WAS RESHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598539 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, A FEW MINUTES FOLLOWING THE TRANSSEPTAL PUNCTURE, A DROP IN SATURATION WAS OBSERVED AND A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE TRANSSEPTAL POSITION WAS ANTERIOR/INFERIOR. THE CAUSE OF THE PERICARDIAL EFFUSION IS UNKNOWN. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25393748 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PFA PROCEDURE WITH A VOLT CATHETER, THE PATIENT BECAME HYPOTENSIVE AND ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGERY. THE PHYSICIAN STATED THAT THE EVENT WAS DUE TO A DIFFICULT TRANSSEPTAL PUNCTURE. TRANSSEPTAL WAS PERFORMED WITH A SWARTZ SHEATH AND BRK NEEDLE. DIFFICULTIES WERE EXPERIENCED DUE TO THE PATIENT'S SPECIFIC ANATOMY. THE GUIDE WAS USED TO CHANGE TO AN AGILIS SHEATH BUT TRANSSEPTAL WAS LOST. TRANSSEPTAL PUNCTURE WAS ABOUT TO BE PERFORMED WITH THE AGILIS SHEATH AND A NEW BRK NEEDLE, HOWEVER IT WAS ADVISED TO PERFORM THE PUNCTURE WITH THE SWARTZ SHEATH AND THE BRK NEEDLE INSTEAD. ABLATION STARTED, HOWEVER, THE PERFORATION WAS THEN NOTED AND A PERICARDIOCENTESIS AND SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT IS STABLE AND THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 25273583 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PFA PROCEDURE WITH A VOLT CATHETER, THE PATIENT BECAME HYPOTENSIVE AND ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGERY. THE PHYSICIAN STATED THAT THE EVENT WAS DUE TO A DIFFICULT TRANSSEPTAL PUNCTURE. TRANSSEPTAL WAS PERFORMED WITH A SWARTZ SHEATH AND BRK NEEDLE. DIFFICULTIES WERE EXPERIENCED DUE TO THE PATIENT'S SPECIFIC ANATOMY. THE GUIDE WAS USED TO CHANGE TO AN AGILIS SHEATH BUT TRANSSEPTAL WAS LOST. TRANSSEPTAL PUNCTURE WAS ABOUT TO BE PERFORMED WITH THE AGILIS SHEATH AND A NEW BRK NEEDLE, HOWEVER IT WAS ADVISED TO PERFORM THE PUNCTURE WITH THE SWARTZ SHEATH AND THE BRK NEEDLE INSTEAD. ABLATION STARTED, HOWEVER, THE PERFORATION WAS THEN NOTED AND A PERICARDIOCENTESIS AND SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT IS STABLE AND THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 25273582 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A THORACOTOMY. RIGHT AFTER PERFORMING THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN NOTICED THAT THE PUNCTURE HAD BEEN PLACED TOO HIGH. EVEN SO, HE ATTEMPTED TO MAP THE LEFT ATRIUM (LA), BUT WITH GREAT DIFFICULTY. AT THAT MOMENT, HE DECIDED TO REDO THE TRANSSEPTAL PUNCTURE, AND MOMENTS AFTER THE SECOND PUNCTURE, HE NOTICED AN EFFUSION IN THE PERICARDIUM, WHICH NEEDED TO BE DRAINED, AND THE PROCEDURE PROGRESSED TO A THORACOTOMY TO CLOSE THE LESION IN THE ROOF OF THE LA. THE PATIENT IS STABLE, AND THE PHYSICIAN STATES IT HAS NO RELATION TO ANY DEFECT OR DAMAGE OF THE DEVICE; IT WAS A FAILURE IN THE PUNCTURE DUE TO THE PATIENT'S DIFFICULT ANATOMY.

  Patient problems: Cardiac Perforation

  MAUDE report 24942056 ↗
• MalfunctionMar 18, 2026Difficult to Insert

  DURING AN AVRT PROCEDURE, DIFFICULTY WAS NOTED DURING TRANSSEPTAL PUNCTURE. THE NEEDLE FAILED TO PASS THROUGH THE SL1 SHEATH DESPITE MULTIPLE ATTEMPTS. THE NEEDLE WAS REPLACED AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED. DURING ABLATION IT WAS NOTED THAT THE CATHETER HAD PRESSURE MALFUNCTION AND COULD NOT ACCURATELY DISPLAY PRESSURE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630288 ↗
• DeathFeb 24, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION WITH PULSED FIELD ABLATION, A CARDIAC EFFUSION OCCURRED THAT RESULTED IN PATIENT DEATH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE BRK NEEDLE AND 13F SHEATH GUIDED BY ETO WITH NO ISSUE. AFTER THE PUNCTURE, A 0.035 WIRE WAS INSERTED INTO THE LSPV AND CONFIRMED BY THE FLUOROSCOPY. THE PFA CATHETER WAS INSERTED INTO THE LA, THE PHYSICIAN FILLED IT AND STARTED THE CONTACT BASELINE ON THE POSTERIOR WALL WITH NO ISSUE. THE LSPV WAS ISOLATED WITH NO ISSUE. THEN THE 0.035 WIRE WAS INSERTED INTO THE LIPV AND CONFIRMED WITH FLUOROSCOPY. THE PHYSICIAN MOVED THE PFA CATHETER AND 13F SHEATH FROM THE LSPV WITH THE 0.35 WIRE RETRIEVED CLOCKWISE AND INSERTED THE GUIDEWIRE INTO THE LIPV. THE PFA CATHETER WAS MOVED TOWARD THE VEIN BUT DURING ISOLATION, THE ANESTHETIST NOTED A DROP ON C02 EXPIRED. THE PHYSICIAN LOOKED ON FLUOROSCOPY AND NOTED NO CARDIAC CONTRACTION. CARDIAC EFFUSION WAS CONFIRMED WITH TTE. A PERICARDIOCENTESIS WAS PERFORMED AND WHILE DRAINING, ADRENALINE WAS INJECTED TO INCREASE CARDIAC RHYTHM. AT THE SAME TIME, A CS CATHETER WAS INSERTED IN THE RV TO STIMULATE BUT THE HEART WAS NOT CONTRACTED, CONFIRMING AN ELECTRO-MECHANIC DISSOCIATION. A CARDIAC

  Patient problems: Cardiac Perforation

  MAUDE report 24431038 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PVI PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. DUAL TRANSEPTAL ACCESS WAS PERFORMED USING ICE IMAGING. THE PATIENT WAS IN SINUS RHYTHM. STANDARD LEFT ATRIAL GEOMETRY AND BASELINE MAPPING WAS PERFORMED. UPON COMPLETION OF MAPPING, A PERICARDIAL EFFUSION WAS NOTED WITH ICE. A PERICARDIOCENTESIS WAS PERFORMED UNDER FLUOROSCOPY. THE PATIENT REMAINED STABLE THROUGHOUT AND WAS TRANSFERRED TO THE WARD WITH NO CHANGE OR INCREASE IN EFFUSION SIZE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24108488 ↗
• 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 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. THE TRANSEPTAL PUNCTURE WAS NOTED TO BE DIFFICULT RELATED TO PATIENT ANATOMY. WHILE MAPPING IN THE LEFT ATRIUM, A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ULTRASOUND WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23648726 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED REQUIRING A PERICARDIOCENTESIS. TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER ECHOCARDIOGRAPHIC GUIDANCE, SEEMINGLY WITHOUT DIFFICULTY. AN ADVISOR FL MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM. SHEATH FILTERING ON ENSITE WAS DIFFICULT. GEOMETRY MAPPING BEGAN BUT THE PHYSICIAN HAD SIGNIFICANT DIFFICULTY NAVIGATING WITHIN THE LEFT ATRIUM AND DECIDED TO REPLACE THE CATHETER WITH A TACTICATH SE ABLATION CATHETER. UPON INTRODUCTION OF THE TACTICATH, IMPEDANCE WAS ELEVATED IN CERTAIN AREAS (>300 OHMS) AND THE GEOMETRY DID NOT MATCH THE CT SCAN. THE PATIENT'S BLOOD PRESSURE DROPPED. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A SIGNIFICANT PERICARDIAL TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PHYSICIAN ALLEGES THE BRK NEEDLE CAUSED OR CONTRIBUTED TO THE TAMPONADE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23645247 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF THE PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE, AN ULTRASOUND WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION WHICH DID NOT REQUIRE ANY TREATMENT. NO PATIENT SYMPTOMS WERE OBSERVED. THE PATIENT IS STABLE. THE PHYSICIAN BELIEVES THE EFFUSION OCCURRED DURING THE TRANSSEPTAL PUNCTURE AND NOTED SOME DIFFICULTY DURING THE TRANSSEPTAL PUNCTURE. THE PHYSICIAN TRIED MULTIPLE TIMES BEFORE HE PERFORMED THE TRANSEPTAL PUNCTURE RELATED TO CHALLENGING PATIENT ANATOMY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23479154 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. THE RIGHT ATRIUM WAS MAPPED AND IT WAS DETERMINED THAT THE LEFT ATRIUM ALSO NEEDED TO BE MAPPED. TRANSSEPTAL WAS PERFORMED BUT WHEN LOOKING AT X-RAY, IT APPEARED A TAMPONADE HAD OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PATIENT WAS ADMITTED TO THE ICU AS A PRECAUTION.

  Patient problems: Cardiac Perforation

  MAUDE report 23463714 ↗

Other St. Jude Medical Cardiovascular Division products

• Angio-Seal6 models · 160 reports
• BRK-16 models · 102 reports
• Pacel9 models · 52 reports
• Supreme16 models · 43 reports
• Safire5 models · 31 reports
• Livewire10 models · 30 reports