NRG Transseptal Needle NRG-E-HF-98-C0 (UDI 00685447000242)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447000242), received between Aug 14, 2023 and Aug 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310228 ↗
• MalfunctionSep 25, 2023Material Integrity Problem; Material Integrity Problem

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN RADIOFREQUENCY (RF) ABLATION PROCEDURE. THE USER HAS STATED THAT THE NEEDLE BECAME FRACTURED DURING PREPARATION AND COULD THEREFORE NOT BE USED. NO TROUBLESHOOTING METHODS HAVE BEEN SPECIFIED. THE NEEDLE WAS THEN REPLACED (DIFFERENT DEVICE, SAME MODEL) AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED OF AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814823 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE. POST PROCEDURE, WHILE THE PATIENT WAS RECOVERING, THEIR BLOOD PRESSURE DECREASED. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, WHICH SHOWED THAT THERE WAS A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND DRAINED 400CCS OF BLOOD FROM THE PERICARDIAL SAC. FOLLOWING THIS, THE PATIENT'S VITAL SIGNS RETURNED TO NORMAL. THE PATIENT IS RECOVERING WELL FROM THIS EVENT AND IS PLANNED TO BE DISCHARGED HOME.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 17544676 ↗