BRK™ 407200Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 05414734205092), received between Jun 25, 2018 and Aug 14, 2026 — classified as 4 deaths, 39 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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, 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 25 most recent of 71 reports, 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 The ablation catheter was then withdrawn into the right atrium, and no satisfactory target site was identified along either the tricuspid annulus or within the coronary venous system.A second TSP was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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TRANSEPTAL PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH RESOLVED ON ITS OWN WITHOUT INTERVENTION. THE PHYSICIAN REPORTED THAT THE FORAMEN OVALE FELT ELASTIC AND HE HAD DOUBTS WHILE USING THE NEEDLE, SO A TRANSESOPHAGEAL ULTRASOUND WAS REQUESTED. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. NO PATIENT SYMPTOMS WERE NOTED. THE PHYSICIAN THINKS TOO MUCH FORCE WAS EXERTED ON THE FORAMEN OVALE WHEN PERFORMING THE TRANSEPTAL WHICH LED TO HIM GOING IN THE PERICARDIUM AND CAUSING THE EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH THE BRK NEEDLE.

  Patient problems: Cardiac Perforation

  MAUDE report 23343518 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A GREAT VESSEL PERFORATION OCCURRED. FOLLOWING TRANSSEPTAL PUNCTURE WITH TEE SUPPORT, AND AN UNCLEAR CONTRAST CLOUD WAS NOTED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PATIENT HAD A CHALLENGING ANATOMY; NO LEFT LUNG AND THEREFORE NOT THE TYPICAL HEART AXIS.

  Patient problems: Great Vessel Perforation

  MAUDE report 22078940 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707009 ↗
• MalfunctionSep 13, 2024Material Twisted/Bent; Material Twisted/Bent

  RELATED MANUFACTURING REFERENCE: 3005334138-2024-00378. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, MATERIAL INTEGRITY ISSUES RESULTED IN A PROCEDURAL DELAY. WHILE PERFORMING THE ATRIAL SEPTAL PUNCTURE, IT WAS NOTED THAT THE NEEDLE TIP WAS BENT AND THE SHEATH TIP WAS FRAYED. THE DEVICES WERE BOTH REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214937 ↗
• InjuryAug 9, 2024Difficult to Insert; Obstruction of Flow; Difficult to Insert; Obstruction of Flow

  THIS REPORT IS TO ADVISE OF A FOREIGN MATERIAL NOTED WITHIN THE NEEDLE HUB OF THE NEEDLE DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951480 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE NEEDLE WAS FRACTURED DURING ATRIAL SEPTAL PUNCTURE. 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 19914728 ↗
• MalfunctionJul 22, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE NEEDLE DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19796885 ↗
• MalfunctionJul 16, 2024Fracture; Material Separation; Fracture; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE DISTAL TIP OF THE NEEDLE WAS NOTED TO BE BROKEN FOLLOWING INSERTION INTO THE PATIENT. THE PRODUCT WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750447 ↗
• InjuryJun 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION WITH A GRADE OF 3 AND ENLARGED ATRIUM, THERE WAS AN EMBOLUS. AFTER PERFORMING TRANSSEPTAL PUNCTURE AND INSERTING A STEERABLE GUIDE CATHETER, A FLOATING STRUCTURE WAS OBSERVED AT THE STEERABLE GUIDE CATHETER AND DILATOR ASSEMBLY, DESPITE A HEPARIN INJECTION AND SUFFICIENT ACT. THE PHYSICIAN SUSPECTED THAT THE FLOATING STRUCTURE WAS A TISSUE PARTICLE OF THE FOSSA, OR A THROMBUS, HOWEVER IT IS UNCONFIRMED. WHILE RETRACTING THE DILATOR, ASPIRATION WAS PERFORMED, AND THE FLOATING STRUCTURE WAS NOT VISIBLE ANYMORE. THE PROCEDURE WAS CONTINUED AND THE MITRACLIP WAS IMPLANTED SUCCESSFULLY, REDUCING THE MR TO A GRADE OF 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 19641135 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. FOLLOWING TRANSSEPTAL PUNCTURE, WHEN BEGINNING MAPPING OF THE LEFT ATRIUM, A TAMPONADE WAS OBSERVED AT LEFT ATRIAL APPENDAGE VIA FLUOROSCOPY. A PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE CONTINUED. ALL VEINS WERE SUCCESSFULLY ISOLATED WITH NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT RETURNED TO RECOVERY WITH AN EPICARDIAL DRAIN IN PLACE. THE PHYSICIAN NOTED THAT THE PATIENT'S LEFT ATRIUM WALL WAS VERY THIN. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES, AND THE PHYSICIAN DOES NOT ALLEGE THAT THE TAMPONADE WAS CAUSED BY AN ABBOTT DEVICE. HOWEVER, THE CAUSE OF THE TAMPONADE IS UNCONFIRMED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 19630662 ↗
• MalfunctionJun 17, 2024Difficult to Insert; Difficult to Insert

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547779 ↗
• MalfunctionJun 3, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION SURGERY, WHEN THE ATRIAL SEPTAL PUNCTURE WAS PERFORMED, IT WAS FOUND THAT THE SHEATH TIP WAS FRAYED AND THE NEEDLE TIP WAS BROKEN. BOTH DEVICES WERE REPLACED AND THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453695 ↗
• MalfunctionMay 8, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHILE PERFORMING THE TRANSSEPTAL PUNCTURE, RESISTANCE WAS NOTED WHEN THE NEEDLE WAS ADVANCED THROUGH THE SHEATH. THE SET WAS REMOVED AND IT WAS CONFIRMED THAT THE NEEDLE WAS FRACTURED. THE NEEDLE AND SHEATH WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE STYLET WAS USED AND THE NEEDLE WAS RESHAPED BEFORE INSERTION INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274126 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MITRACLIP PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS FOLLOWED BY OPEN HEART SURGERY TO STABILIZE THE PATIENT. THE PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND PROLAPSED POSTERIOR LEAFLET. A STEERABLE GUIDE CATHETER (SGC) WAS INSERTED WITHOUT ISSUES. HOWEVER, WHILE ADVANCING THE CLIP DELIVERY SYSTEM (CDS), A PERFORATION FROM THE LEFT ATRIUM WAS OBSERVED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION. IN THE PHYSICIAN'S OPINION, THE STEERABLE GUIDE CATHETER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PERICARDIAL EFFUSION. THE SGC AND CDS WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS DISCONTINUED WITH NO CLIPS IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM (OR) FOR OPEN HEART SURGERY. SUBOPTIMAL TRANSSEPTAL PUNCTURE DUE TO "FLOPPY" SEPTUM WAS NOTED. THE PATIENT REMAINS IN THE HOSPITAL. THERE WERE NO REPORTED PERFORMANCE ISSUES WITH THE NEEDLE. THE PHYSICIAN THINKS DUE TO THE MORPHOLOGY OF THE SEPTUM (FLOPPY) WHEN HE ADVANCED THE SGC, THE TENSION WAS RELEASED AND, THE TIP OF THE SGC CAUSED T

  Patient problems: Cardiac Perforation

  MAUDE report 19214328 ↗
• InjuryMar 29, 2024Difficult to Insert; Difficult to Insert

  MANUFACTURING REF: 3005334138-2024-00108. DURING AN ATRIAL FIBRILLATION PROCEDURE, A SHEATH WAS FRACTURED, AND A TAMPONADE AND THROMBUS OCCURRED REQUIRING A PERICARDIOCENTESIS. AFTER INSERTING THE SHEATH INTO THE PATIENT, THERE WAS DIFFICULTY PASSING THE TRANSSEPTAL NEEDLE. THE SHEATH AND NEEDLE WERE REMOVED, AND IT WAS NOTED THAT THE SHEATH WAS FRACTURED. THE SHEATH WAS REPLACED AND A NEW TRANSSEPTAL PUNCTURE WAS ATTEMPTED. HOWEVER, A TAMPONADE WAS THEN NOTED IN THE RIGHT ATRIUM CLOSE TO THE SEPTUM. IT WAS ALSO NOTED THAT THE SHEATH WAS NOT FIXED WELL TO THE SEPTUM. THE THROMBUS WAS SEEN THROUGH THE TRANSESOPHAGEAL ECHOCARDIOGRAM WHERE THE PROCEDURE WAS INTERRUPTED. A PERICARDIOCENTESIS WAS PERFORMED, STABILIZING THE PATIENT. THE PATIENT WAS THEN TAKEN TO THE ICU FOR FOLLOW-UP. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED BEFORE THE PROCEDURE, BUT NO THROMBUS WAS NOTED.

  Patient problems: Cardiac Perforation; Thrombosis/Thrombus

  MAUDE report 19003589 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATYPICAL ATRIAL FLUTTER, TRANSSEPTAL PUNCTURE WAS COMPLETED AND A TAMPONADE WAS NOTED AT THE AORTIC ROOT AND THE PROCEDURE WAS STOPPED. THE DIAGNOSIS WAS ASSURED BY A MEANS OF CONTRAST. HOWEVER, THE PATIENT WAS MONITORED FOR 1 HOUR IN THE SURGICAL ROOM AND WAS STABLE, WITHOUT A DROP IN BLOOD PRESSURE OBSERVED. AN ECHOCARDIOGRAM WAS DONE TO VERIFY THE PERFUSION, WHICH WAS NOT AS VISIBLE. THE PATIENT WAS MONITORED IN THE SUB-INTENSIVE ROOM OVERNIGHT.

  Patient problems: Cardiac Perforation

  MAUDE report 18441623 ↗
• InjuryDec 20, 2023Device Contamination with Body Fluid; Patient Device Interaction Problem; Device Contamination with Body Fluid; Patient Device Interaction Problem

  FDA REQUEST TO UPDATE DEVICE MODEL INFORMATION AND CORRECTED REPORTABLE AWARE DATE. FOLLOW UP REPORT REQUIRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18367009 ↗
• MalfunctionDec 1, 2023Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00547. DURING AN ATRIAL FIBRILLATION ABLATION CASE, WHILE PREPARING FOR THE TRANSSEPTAL PUNCTURE, RESISTANCE WAS NOTED WHEN INSERTING THE BRK NEEDLE INTO THE SHEATH AND THE NEEDLE COULD NOT BE ADVANCED. THE SHEATH WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE SHEATH WAS REPLACED A SECOND TIME BUT THE ISSUE STILL PERSISTED, AND IT WAS NOTED THAT THE NEEDLE PUNCTURED THE LONG SHEATH AND DILATOR. THE SHEATH AND NEEDLE WERE BOTH REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THE STYLET WAS NOT USED AND THE NEEDLE WAS RESHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247593 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. A PERICARDIAL CONTRAST INJECTION WAS PERFORMED DURING THE TRANSSEPTAL PUNCTURE. A SECOND TRANSSEPTAL PUNCTURE WAS DONE WITH THE ASSIST OF ECHOCARDIOGRAPHY. AFTER FINISHING COLLECTING GEOMETRY, A BLOOD PRESSURE DECREASE FROM SYSTOLIC OF 120 TO A SYSTOLIC OF 40 WAS OBSERVED. THE PROCEDURE WAS STOPPED AND AN ECHOCARDIOGRAM WAS DONE WHICH CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THERE WERE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 17952833 ↗