BRK-1Recalls & reported problems across all models

We found 6 models of BRK-1 by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2018 and Aug 19, 2026 — classified as 4 deaths, 83 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (10 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-1 problems

BRK-1 models

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

• BRK-1™ G407209

  Trocar
  4 deaths50 reports
• BRK-1™ 407201

  Trocar
  30 reports
• BRK-1™ G407212

  Trocar
  12 reports
• BRK-1™ 407207

  Trocar
  6 reports
• BRK-1™ G407215

  Trocar
  3 reports
• BRK-1™ G407216

  Trocar
  1 report

Recent BRK-1 adverse event reports

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

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  During the procedure, a pericardial effusion was noted while using a BRK needle. While attempting transseptal puncture, it was aborted due to significant atrial anatomical distortion from previous cardiac surgery. The pericardial effusion was noted during ablation of the cavotricupsid isthmus. A pericardiocentesis was perform with 120 ml of blood drained. The patient stabilized with no growth of the effusion. The patient remained stable with no complication after the pericardiocentesis.

  Patient problems: Cardiac Perforation

  MAUDE report 50330766 ↗
• MalfunctionAug 3, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118948 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  During the PFA procedure, a cardiac perforation was noted after CT surgery. After inserting the ICE catheter, the physician noted that the patient had a thick, calcified superior limbus (~2.5cm) and ICE imaging of the LA was difficult to see because of it. Transseptal was performed with a BRK needle through an Agilis 13F sheath. During this process, the needle was difficult to visualize in the LA. After taking the needle out and inserting a Volt catheter, a 1 cm effusion was noted. No ablations were performed with the Volt catheter and baseline was not performed yet. The chest was tapped and about 3.5L of blood was tapped and reinfused while preparing for surgery. During CT surgery, a 1cm hole was noted in the LAA. The LAA was sutured and the patient is now stable.

  Patient problems: Cardiac Perforation

  MAUDE report 50071745 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A HEMOPERICARDIUM WAS NOTED DURING TRANSSEPTAL PUNCTURE. A DROP IN BLOOD PRESSURE WAS NOTED, AND AN ECHOCARDIOGRAM WAS PERFORMED TO CONFIRM THE HEMOPERICARDIUM. THE PROCEDURE WAS CANCELLED AT THIS TIME, AND THE PATIENT UNDERWENT SURGICAL INTERVENTION TO FIX THE HEMOPERICARDIUM. THERE WERE NO OTHER ADVERSE PATIENT HEALTH CONSEQUENCES AND THE PATIENT IS STABLE AFTER INTERVENTION. IT IS ALLEGED THAT THE PUNCTURE WAS IN THE WRONG PLACE AND THAT THERE IS NO ALLEGED COMPLAINT ON THE ABBOT DEVICE. THE PERFORATION IS LOCATED ON THE ROOF OF THE RIGHT ATRIUM. IT WAS NOTED THAT THE PATIENT HAS A PRIOR HISTORY OF STENT PLACEMENT.

  Patient problems: Cardiac Perforation

  MAUDE report 25677120 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING COMPLETION OF A PVI PROCEDURE, A FOLLOW-UP EXAMINATION WAS PERFORMED, AND AN ULTRASOUND REVEALED A SMALL EFFUSION OVER THE RIGHT ATRIUM. THE PATIENT WAS MONITORED WITH NO ADDITIONAL INTERVENTION ADMINISTERED. IT WAS NOTED THAT THE TRANSSEPTAL PUNCTURE WAS DIFFICULT AND THE PATIENT HAD ABNORMAL CARDIAC ANATOMY. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25487576 ↗
• MalfunctionMay 5, 2026Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, THERE WAS A DELAY OF PROCEDURE WHEN THE SHEATH AND THE NEEDLE WERE PREPARED FOR TRANSSEPTAL PUNCTURE. AN OBSTRUCTION WAS NOTED WITHIN THE SHEATH AS THE NEEDLE COULD NOT BE INSERTED THROUGH THE DILATOR. THE SHEATH, DILATOR, AND THE NEEDLE WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089277 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  AFTER AN OPAL NON-ABBOTT (FARAPULSE PFA BY BOSTON SCIENTIFIC) PROCEDURE, THE CATHETERS WERE TO BE REMOVED WHEN THE PATIENT'S HEART RATE INCREASED AND THE BLOOD PRESSURE DECREASED. AN EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 60 ML OF FLUID WAS REMOVED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS USED FOR THE WHOLE PROCEDURE. THE CAUSE OF THE EFFUSION WAS BELIEVED TO BE A FLAP OF TISSUE WHICH WAS PRESENT AT THE FOSSA WHEN PERFORMING THE TRANSSEPTAL PUNCTURE. DUE TO CHALLENGING PATIENT ANATOMY, THE PHYSICIAN REPLACED THE SL0 SHEATH DURING THE TRANSEPTAL PUNCTURE TO BE SURE THE ISSUE WAS NOT RELATED TO THE SHEATH, WHICH IT WAS NOT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24819096 ↗
• DeathApr 1, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI), THE NON-ABBOTT CATHETER (FARAPULSE BY BOSTON SCIENTIFIC) WAS WITHDRAWN BACK INTO THE RIGHT ATRIUM. THE PERICARDIUM WAS PUNCTURED AND BLOOD WAS WITHDRAWN FROM THE PERICARDIAL SAC. WHEN THE BLOOD PRESSURE DID NOT STABILIZE, CHEST COMPRESSIONS WERE INITIATED. ANTICOAGULANTS WERE ADMINISTERED. THE PATIENT EXPERIENCED ASYSTOLE FOLLOWED BY A DROP IN BLOOD PRESSURE. AN ULTRASOUND WAS PERFORMED, REVEALING A PERICARDIAL TAMPONADE. A PERICARDIOCENTESIS WAS THEN PERFORMED. THE BLOOD PRESSURE DID NOT STABILIZE. RESUSCITATION EFFORTS CONTINUED BUT WERE UNSUCCESSFUL. THE PATIENT DIED ON THE OPERATING TABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE PHYSICIAN THINKS THE PERFORATION POSSIBLE OCCURRED AFTER THE FIRST ENERGY RELEASE.

  Patient problems: Asystole; Cardiac Perforation

  MAUDE report 24753092 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE AORTA WAS PUNCTURED WITH THE NEEDLE. WHEN ATTEMPTING TO PERFORM TRANSSEPTAL PUNCTURE WITH THE NEEDLE, THE NEEDLE MOVED TO THE OTHER SIDE AND THE AORTA WAS PUNCTURED. THE PROCEDURE WAS STOPPED AND INTERVENTION WAS PERFORMED. THE PATIENT WAS NOT STABLE WHEN LEAVING THE HOSPITAL AND WAS ON THE WAY TO ANOTHER HOSPITAL FOR AN EMERGENCY OPERATION. THE PATIENT HAD HEART SURGERY BEFORE, SO THE ANATOMY WAS DIFFERENT THAN THE PHYSICIAN EXPECTED. THERE WERE NO PERFORMANCE ISSUES NOTED WITH ANY ABBOTT DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24743552 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PFA ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WHICH REQUIRED SURGERY TO REPAIR. AFTER AN INITIAL VENOGRAPHY WITH THE NON-ABBOTT DEVICE (CORDIS MPA2), A STAINING PHENOMENON WAS NOTED ON THE ROOF OF THE LEFT ATRIUM AND DURING A MANEUVER TO CANNULATE THE RIGHT SUPERIOR PULMONARY VEINS BY ROTATING THE AGILIS 13F SHEATH AND ADVANCING THE NON-ABBOTT DEVICE (GUIDEWIRE BY COOK MEDICAL ROSEN) WITH THE VOLT CATHETER BALLOON INSIDE THE SHEATH. WHEN THE TAMPONADE WAS OBSERVED, A PERICARDIOCENTESIS WAS PERFORMED BUT THE BLEEDING CONTINUED SO CARDIAC SURGERY WAS DONE WHICH REVEALED A PERFORATION IN THE LEFT ATRIAL ROOF. IT IS BELIEVED THAT BASED ON THE LOCATION OF THE PERFORATION, THE EVENT WAS CAUSED BY THE TRANSSEPTAL PUNCTURE. THE PATIENT IS NOW STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24497175 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, FOLLOWING THE TRANSESOPHAGEAL ECHO GUIDED TRANSEPTAL, A PERICARDIAL EFFUSION WAS DIAGNOSED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. HEPARIN REVERSAL WAS ADMINISTERED. THE PATIENT IS STABLE. THE PHYSICIAN ALLEGES THE TRANSSEPTAL PUNCTURE BEING TOO POSTERIOR AS THE CAUSE FOR THE PERICARDIAL EFFUSION. THERE WERE NO ISSUES NOTED DURING THE TRANSSEPTAL PUNCTURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23989255 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A PERICARDIAL EFFUSION/TAMPONADE WAS NOTED, RESULTING IN A PERICARDIOCENTESIS. POST TRANSSEPTAL PUNCTURE, THE NON-ABBOTT CATHETER (QDOT) WAS ADVANCED INTO THE PERICARDIAL SPACE. THERE WAS RESTRICTED MOVEMENT, SO THE CATHETER REMOVED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS ABANDONED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. THE PHYSICIAN ALLEGES THE TRANSSEPTAL PUNCTURE NEEDLE TO BE THE CAUSE.

  Patient problems: Cardiac Perforation

  MAUDE report 23786595 ↗
• InjuryNov 30, 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 PHYSICIAN ALLEGES THAT THE EFFUSION WAS CAUSED BY THE TRANSEPTAL PUNCTURE. THERE WAS A MISUNDERSTANDING BETWEEN THE PHYSICIAN AND THE ANESTHETIST THAT WAS MANIPULATING THE ECHO FOR THE TRANSEPTAL PUNCTURE. AFTER COMPLETING THE TRANSEPTAL, THE FACE OF THE PATIENT WAS BECOMING PURPLE AND THE BLOOD PRESSURE WENT DOWN. THE ESOPHAGEAL ECHO WAS CHECKED WHICH REVEALED A PERICARDIAL EFFUSION. THE PERFORATION WAS LOCATED AT THE LEFT ATRIAL APPENDAGE. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT STABILIZED AND WAS SENT TO THE INTENSIVE CARE UNIT UNDER OBSERVATION. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT PRODUCTS.

  Patient problems: Cardiac Perforation

  MAUDE report 23677137 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. THE ACCESS TO THE LEFT ATRIUM WAS COMPLEX AND REQUIRED REPEATED ATTEMPTS DUE TO PATIENT ANATOMY. THE SL1 WAS USED WITH THE BRK FOR THE TRANSSEPTAL PUNCTURE WHICH REQUIRED MULTIPLE ATTEMPTS. THE SL1 WAS REPLACED BY THE AGILIS 13F WHICH WAS DIFFICULT TO ADVANCE. AFTER MULTIPLE INSERTION ATTEMPTS, THE DILATOR WAS OBSERVED TO BE BENT. THE AGILIS 13F WAS CHANGED TO A NON-ABBOTT SHEATH (FARADRIVE BY BOSTON SCIENTIFIC). PFA WAS SUCCESSFUL USING THE NON-ABBOTT CATHETER (FARAWAVE BY BOSTON SCIENTIFIC). APPROXIMATELY 45 MINUTES POST-PROCEDURE, WHILE IN THE RECOVERY AREA, THE PATIENT BECAME HYPOTENSIVE AND REPORTED SHORTNESS OF BREATH AND DIZZINESS. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH REVEALED A MODERATE PERICARDIAL EFFUSION COMPARED TO THE PRE-PROCEDURE TTE WHICH HAD SHOWN A SMALL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGES THE LEFT ATRIUM POSTERIOR WALL WAS ACCIDENTALLY PERFORATED BY THE BRK NEEDLE AS IT WAS NOTED THE TRANSSEPTAL CROSSING WAS DIFFICULT DUE TO CHALLENGING PATIENT ANATOMY AND REQU

  Patient problems: Cardiac Perforation

  MAUDE report 23551293 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS RECEIVED FROM A VOLUNTARY MEDWATCH REPORT: DURING AN ATYPICAL FLUTTER PROCEDURE, A CARDIAC PERFORATION OCCURRED WHICH DID NOT REQUIRE ANY INTERVENTION. THE RIGHT ATRIAL MAP WAS PERFORMED WITH A NON-ABBOTT CATHETER (OCTARAY BY JOHNSON AND JOHNSON). TRANSSEPTAL PUNCTURE WAS DONE TO ACCESS THE LEFT ATRIUM. THE PHYSICIAN NOTICED SHE PUNCTURED THE SEPTUM AND GOT INTO THE PERICARDIUM. THE PATIENT BLOOD PRESSURE WAS STABLE. THE SHEATH WAS RETRIEVED AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED AGAIN. THE LEFT ATRIAL MAP WAS PERFORMED WITH THE NON-ABBOTT CATHETER (OCTARAY BY JOHNSON AND JOHNSON). ABLATION WAS DONE WITH THE NON-ABBOTT CATHETER (SMARTTOUCH SURROUND FLOW BY JOHNSON AND JOHNSON). THE PROCEDURE FINISHED SUCCESSFULLY. LATER IN THE DAY, AN ECHOCARDIOGRAM WAS PERFORMED, AND NO TAMPONADE WAS FOUND. THE PATIENT WAS STABLE. THE NEXT DAY THE PATIENT WAS STILL STABLE WITH NO SYMPTOMS RELATED TO THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Cardiac Perforation

  MAUDE report 23479996 ↗

Other St. Jude Medical Cardiovascular Division products

• BRK4 models · 177 reports
• Angio-Seal6 models · 160 reports
• Pacel9 models · 52 reports
• Supreme16 models · 43 reports
• Safire5 models · 31 reports
• Livewire10 models · 30 reports