NRG Transseptal Needle NRG-71-C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447000020), received between May 23, 2019 and May 23, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYLIS MEDICAL WAS INFORMED OF A PULMONARY VEIN ISOLATION (PVI) PROCEDURE IN WHICH THE NRG TRANSSEPTAL NEEDLE WAS USED FOR TRANSSEPTAL PUNCTURE AND A COMPLICATION OCCURRED. THE PHYSICIAN PERFORMED TWO TRANSSEPTAL PUNCTURES WITH THE NRG NEEDLE THROUGH A SL1 SHEATH WITH NO ISSUE. THE PHYSICIAN PULLED OUT THE NRG NEEDLE TO EXCHANGE FOR AN AGILIS SHEATH. NO BAYLIS PRODUCTS WERE USED AGAIN OR PLACED INSIDE THE PATIENT. THE PHYSICIAN LOST ACCESS WITH THE AGILIS SHEATH BUT WAS LATER ABLE TO CROSS AGAIN THROUGH THE SAME PUNCTURE SITE. THE CASE PROCEEDED AND LATER, A PERFORATION WAS DISCOVERED. THE PATIENT WAS DEEMED STABLE AND DID NOT HAVE TO LEAVE THE CATHETERIZATION LAB BUT THE PROCEDURE WAS ABORTED. THE NURSING STAFF INDICATED THAT THE PHYSICIAN FELT THAT THE BAYLIS NRG TRANSSEPTAL NEEDLE NRG NEEDLE WAS NOT RESPONSIBLE FOR THE PERFORATION. THE NURSING STAFF STATED THAT VERY HIGH CONTACT FORCE WAS OBSERVED ON THE MAPPING SYSTEM THROUGHOUT THE PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO

  Patient problems: Cardiac Perforation

  MAUDE report 8637312 ↗