BRK-1™ G407212Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734205191), received between Apr 19, 2019 and Jul 1, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  RELATED MANUFACTURING REF: 3008452825-2023-00030. DURING A RIGHT AND LEFT ATRIAL PROCEDURE IN A PATIENT WITH A CONGENITAL HEART DEFECT AND JUNCTIONAL ECTOPIC TACHYCARDIA, CRYO ABLATION WAS PERFORMED IN BOTH THE LEFT AND RIGHT ATRIUM WITH A MEDTRONIC FREEZR. AFTER THE PROCEDURE WAS FINISHED, AN UNKNOWN PARTICLE WAS NOTED IN THE LEFT ATRIUM IN THE ULTRASOUND IMAGING. THE PARTICLE COULD BE A THROMBUS BUT COULD NOT BE CONFIRMED DURING PROCEDURE. IT WAS ALSO THOUGHT TO BE A PARTICLE FROM AN INSERTED PRODUCT. IN PRIOR ULTRASOUND IMAGING BEFORE THE PROCEDURE THE PARTICLE WAS CLEARLY NOT VISIBLE IN THE PATIENT'S LEFT ATRIUM. THE PHYSICIAN INSPECTED THE AGILIS AND BRK AFTER EXTRACTION AND DID NOT NOTICE ANY DEFECT. THE PROCEDURE WAS FINISHED AS PLANNED AND THE PATIENT WAS STABLE AND SENT TO THE ICU FOR FURTHER OBSERVATION. THE PARTICLE NOT RETRIEVED, AS IT WAS HOPED IT WAS A THROMBUS THAT COULD BE HEPARINIZED. FOLLOWING PROCEDURE, THE PATIENT WAS ANTICOAGULATED, AND THE PARTICLE WAS NOT VISIBLE THE NEXT DAY, THUS THE PHYSICIAN SAYS IT WAS A THROMBUS. THE PATIENT IS STABLE AND WAS DISMISSED FROM THE HOSPITAL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16244856 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THERE WAS AN AORTIC PERFORATION. DURING TRANSSEPTAL PUNCTURE, THERE WAS A CHANGE IN ARTERIAL PRESSURE. AN ECHOCARDIOGRAM SHOWED A PERFORATION OF THE AORTA WITH LIMITED BLOOD COLLECTION ON THE AORTA WALL. A COMPUTERIZED TOMOGRAPHY SCAN WAS TAKEN AND CONFIRMED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS CANCELLED, AND NO ADDITIONAL TREATMENT WAS NECESSARY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 11275821 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A CARDIA TAMPONADE OCCURRED. THE PATIENT'S BLOOD PRESSURE DECREASED SLOWLY DURING THE PROCEDURE AND WHEN THE SBP WAS AT 59 MMHG A CARDIAC ECHO WAS PERFORMED AND A CARDIAC TAMPONADE WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED WITH THE SBP RETURNING TO NORMAL. THE PHYSICIAN STATED THE PERFORATION OCCURRED DURING THE TRANSSEPTAL PUNCTURE WHEN THE PATIENT BEGAN TO COUGH AT THE MOMENT THE NEEDLE EXITED THE SHEATH. DURING THE PROCEDURE THERE WAS NO EXCESSIVE FORCE NOTED TO BE SEEN ON THE ABLATION CATHETER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES

  Patient problems: Cardiac Perforation

  MAUDE report 10779728 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00420, 3005334138-2020-00365, 9680001-2020-00047. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. ACCESS WAS OBTAINED VIA TRANSSEPTAL PUNCTURE AND MAPPING WAS COMPLETED. FOLLOWING MAPPING THE ABLATION CATHETER WAS INTRODUCED AND USED TO ISOLATE THE VEINS. AFTER ABLATION THE PATIENT REPORTED CHEST PAIN AND TIGHTNESS. AN ECHOCARDIOGRAM CONFIRMED AN EFFUSION IN THE PERICARDIUM. HEPARIN WAS REVERSED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10430406 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-00321, 3008452825-2020-00322. DURING A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE AND DISSECTION OCCURRED. DIFFICULTY WAS NOTED DURING CATHETERIZATION OF THE VEIN OF MARSHALL AND A CORONARY SINUS DISSECTION OCCURRED. WHEN APPLYING THE 4TH RF APPLICATION ON THE MITRAL ISTHMUS, THE PATIENT¿S BLOOD PRESSURE COLLAPSED AND AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER THE PATIENT WAS UNSTABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation; Vascular Dissection

  MAUDE report 10190081 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 2182269-2020-00020, 2182269-2020-00021, 3008452825-2020-00113, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744977 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00263, 2030404-2019-00040, 2182269-2019-00076. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THERE WERE NO PATIENT SYMPTOMS. THE EFFUSION WAS DIAGNOSED BY TRANSTHORACIC ECHOCARDIOGRAM. THE LEFT ATRIUM WAS REACHED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND AFTER BEING FOLLOWED UNDER INTENSIVE CARE FOR OBSERVATION. IT WAS INDICATED THE PUNCTURE WAS DIFFICULT AND THE AORTIC BULB MAY HAVE BEEN PUNCTURED. THERE WAS NO INDICATION THAT AN ABBOTT DEVICE CAUSED THE EVENT, BUT THE CAUSE COULD NOT BE CONFIRMED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8669861 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. NEAR THE END OF THE PROCEDURE, WHEN FINISHING THE CAVO-TRICUSPID ISTHMUS ABLATION LINE, IT WAS NOTED THAT THE LEFT VENTRICLE DID NOT APPEAR TO BE CONTRACTING WELL. THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAPHY AND ULTRASOUND CONFIRMED THE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8634137 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00217, 3008452825-2019-00190, 3008452825-2019-00191, 3008452825-2019-00193, 3008452825-2019-00194, 3005334138-2019-00218, 3005334138-2019-00219. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED. SEVERAL MINUTES AFTER ABLATING THE RIGHT VENTRICLE, THE PATIENT BECAME HYPOTENSIVE. TRANSESOPHAGEAL ECHOGRAPHY REVEALED A TAMPONADE. A THORACOTOMY WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8533277 ↗