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BRK-1™ G407216Recalls & reported problems

St. Jude Medical Cardiovascular Division · XS Transseptal Needle · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734207232), received between Mar 8, 2019 and Mar 8, 2019 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A DAY AFTER THE RADIO FREQUENCY PROCEDURE, A PERICARDIAL EFFUSION IN THE LEFT ATRIUM ON THE POSTERIOR WALL OCCURRED DURING A TRANSSEPTAL PUNCTURE WITH THE NEEDLE. THE EFFUSION WAS OBSERVED BY AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 500 CC OF BLOOD WAS DRAINED. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICE. CONCOMITANT DEVICES INCLUDE: TACTICATH SE, INQUIRY, ADVISOR, SL0 INTRODUCER.

    Patient problems: Cardiac Perforation

    MAUDE report 8405830 ↗

Other Trocar devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.