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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447004448), received between Aug 4, 2026 and Aug 4, 2026 — 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

Recent adverse event reports

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

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced ST segment elevation and hypotension during a procedure. They received oxygen, vasopressors, and pacing resolving the issue and allowing the procedure to be completed without further complications.A FARAPULSE procedure to treat paroxysmal atrial fibrillation was performed. An NRG Transseptal Needle was selected for use. After the transseptal access was achieved with the needle, a non-Boston Scientific sheath was advanced into the left atrium of the patient. At this time, ST segment elevation was observed on inferior leads II, III, and aVf. Hypotension was also noted. No air was observed in a device or the patient. The patient, under anesthesia, was treated with oxygen, vasopressors, and pacing to increase heart rate. The physician also evaluated the heart using Intracardiac echocardiography (ICE). No effusion or wall motion abnormalities were observed. After a few minutes, the patient condition resolved. The procedure was completed as expected with no further complications and is in stable condition.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50127706 ↗