BRK-1™ 407207Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734205177), received between Oct 7, 2020 and Jul 29, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TRANSSEPTAL NEEDLE BROKE WHEN PLACING THE PUNCTURE. THE NEEDLE WAS ABLE TO BE REMOVED FROM THE PATIENT AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645409 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TRANSESOPHAGEAL ECHOCARDIOGRAM PERFORMED PRIOR TO A REPEAT ABLATION SHOWED AN ATRIAL LEFT-RIGHT SHUNT. IT IS POSSIBLE THAT THE SHUNT WAS CAUSED BY TRANSSEPTAL PUNCTURED DURING THE REGISTRY PROCEDURE. THERE WAS NO INTERVENTION REQUIRED TO TREAT THE SHUNT. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 19378833 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION / ATRIAL FIBRILLATION ABLATION PROCEDURE, AN EFFUSION OCCURRED. THERE WERE NO DIFFICULTIES OBTAINING VENOUS ACCESS OR PLACING THE CS CATHETER OR MAPPING THE RIGHT ATRIUM. WHILE PREPARING TO ACCESS THE LEFT ATRIUM THROUGH TRANSSEPTAL ACCESS, THE PHYSICIAN NOTED THE PATIENT HAD A THICK SEPTUM WHICH WAS CONFIRMED VIA ICE. TRANSSEPTAL ACCESS WAS ATTEMPTED MULTIPLE TIMES AND ALTHOUGH ACCESS WAS OBTAINED WITH THE BRK-1 NEEDLE, THE INTRODUCER COULD NOT BE ADVANCED. THE INTRODUCER EVENTUALLY ADVANCED AND A SMALL EFFUSION WAS NOTED POST TRANSSEPTAL ACCESS. THE CASE THEN PROCEEDED WITH A MAP OF THE LEFT ATRIUM AND THEN ABLATION. AN ECHO TECH CAME IN MULTIPLE TIMES THROUGHOUT THE PROCEDURE TO MONITOR THE EFFUSION. THE LEFT PULMONARY VEINS AND PART OF THE POSTERIOR WALL WERE ISOLATED WHEN THE EFFUSION BECAME LARGER AND THE PHYSICIAN ELECTED TO ABANDON THE CASE. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN FELT THE EFFUSION OCCURRED DURING TRANSSEPTAL ACCESS AND GIVING HEPARIN DURING THE PROCEDURE CAUSED ENLARGEMENT OF THE EFFUSION. HE ALSO INDICATED, THIS WAS ANATOMY RE

  Patient problems: Cardiac Perforation

  MAUDE report 14166427 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, AN EFFUSION OCCURRED. FOLLOWING TRANSSEPTAL PUNCTURE, AN EFFUSION WAS SUSPECTED. TWO ECHOCARDIOGRAMS WERE PERFORMED AND A SMALL EFFUSION ON THE POSTERIOR WALL WAS CONFIRMED. THE PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE. DURING POST LEFT ATRIAL MAPPING, THE PATIENT'S ARTERIAL LINE PRESSURE DROPPED DOWN TO 45/40. ANOTHER ECHO WAS PERFORMED AND REVEALED THE EFFUSION HAD BECOME MODERATE. A DRAIN WAS PLACED IN THE EPICARDIAL SAC AND A FINAL ECHO REVEALED THE EFFUSION HAD DECREASED AND WAS NO LONGER GROWING. THE DRAIN WAS REMOVED AND THE PATIENT WENT TO THE ICU. THE PHYSICIAN SUSPECTED THE TRANSSEPTAL NEEDLE AS CAUSAL DEVICE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT PRODUCT.

  Patient problems: Cardiac Perforation

  MAUDE report 11977363 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-00522, 3005334138-2020-00469, 3008452825-2020-00523. DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED FOLLOWING TRANSSEPTAL PUNCTURE AND COLLECTION OF LEFT ATRIUM POINTS. AN ICE CATHETER CONFIRMED THE EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10642540 ↗