NRG Transseptal Needle NRG-E-98-C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447000198), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. 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.

• MalfunctionSep 17, 2024Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR ATRIAL FIBRILLATION (A FIB) ABLATION. DURING THE PROCEDURE, THE NRG NEEDLE WAS ADVANCED 2 CM FROM THE TIP OF DILATOR. WHEN RETRACTING SHEATH AND DILATOR TOGETHER TO EXPOSE NRG NEEDLE, ITS TIP WOULD NOT MOVE PAST THE TIP OF THE DILATOR. THUS, WHEN THE NRG NEEDLE WAS REMOVED FROM THE DILATOR, IT WAS NOTED TO HAVE ITS TIP DAMAGED, ITS DISTAL END WAS STRIP OFF. THE NEEDLE WAS THEN REPLACED, NON-BOSTON SCIENTIFIC NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT RETURNING AS DISCARDED IN FACILITY. NO OTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240706 ↗