NRG Transseptal Needle NRG-E-HF-98-C1 (UDI 00685447000259)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00685447000259), received between Mar 26, 2019 and Aug 28, 2026 — classified as 1 death, 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508441 ↗
• DeathApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC ROOT PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED DURING PRE IMAGING. DUE TO CHALLENGING ANATOMY, TORTUROUS VESSELS AND A DILATED RIGHT ATRIUM, THE PHYSICIAN UTILIZED MULTIPLE TRANSEPTAL DEVICES TO ATTEMPT TO GAIN ACCESS. PHYSICIAN ATTEMPTED TRANSSEPTAL PUNCTURE USING VERSACROSS CONNECT LAAC, VERSACROSS ACCESS SOLUTION AND NRG TRANSSEPTAL NEEDLE. WHEN THE PHYSICIAN WAS ATTEMPTING TO CROSS WITH THE NRG, PATIENT BLOOD PRESSURE DROPPED. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING WAS UTILIZED TO EVALUATE FOR EFFUSION. IT WAS IMMEDIATELY NOTED FLUID COMPRESSING THE LEFT ATRIUM. ARTERIAL ACCESS WAS OBTAINED, FLOUROSCOPY IMAGING WAS PREFORMED WHICH REVEALED A PERFORATION IN THE AORTIC ROOT. THE PATIENT HAD PREVIOUS CORONARY ARTERY BYPASS GRAFTING (CABG), SO THIS WAS NOT A PERICARDIAL EFFUSION, IT WAS AN EFFUSION CAUSING EXTRINSIC COMPRESSION OF THE LEFT ATRIUM. THE EFFUSION WAS EVENTUALLY LARGE ENOUGH TO CAUSE COMPLETE CHAMBER COLLAPSE. THE HOSPITAL INITIATED

  Patient problems: Cardiac Tamponade; Hematoma; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 24901357 ↗
• InjuryDec 11, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PULSE FIELD ABLATION (PFA) FOR ATRIAL FIBRILLATION. THE TRANSSEPTAL PUNCTURE WITH AN NRG NEEDLE WAS CHALLENGING. AFTER THE CASE, A PERICARDIAL EFFUSION BEYOND BASELINE WAS NOTED. THE PATIENT WAS MONITORED FOR 10 MINUTES AND THE PHYSICIAN DECIDED TO PERFORM A PERICARDIOCENTESIS. 500 ML OF FLUID WAS REMOVED FROM THE PERICARDIUM WITHOUT INCIDENT. THE BLOOD PRESSURE OF THE PATIENT STABILIZED, BUT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR CLOSER MONITORING. THE PATIENT WAS EXPECTED TO FULLY RECOVER. THE PHYSICIAN BELIEVED THAT THIS EVENT MAY HAVE HAPPENED DURING TRANSSEPTAL PUNCTURE. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED. THE PATIENT WAS DISCHARGED HOME TWO DAYS AFTER THE INCIDENT. THE PHYSICIAN BELIEVED THAT THIS EVENT MAY HAVE BEEN RELATED TO THE CORONARY SINUS (CS) CATHETER. THE PHYSICIAN COULD NOT PLACE THE CS CATHETER INTO THE CS AND NOTABLE EFFORT WAS REPORTED TO PLACE THE CATHETER.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23782370 ↗
• MalfunctionSep 10, 2024Failure to Deliver Energy; Defective Device; Material Integrity Problem; Failure to Deliver Energy; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR ATRIAL FIBRILLATION. DURING THE PROCEDURE, IT WAS TRIED TO DELIVER RF TWICE IN ORDER TO PUNCTURE THE SEPTUM, HOWEVER, IT WAS NOT SUCCESSFUL. THUS, THE NRG NEEDLE WAS PULLED OUT AND IT WAS NOTED THAT IT WAS DAMAGED; THERE WAS AN EXPOSED METAL AND DELAMINATED COATING AT ITS DISTAL END. THE INSULATION WAS PEELING BACK. THEREFORE, THE NRG RF NEEDLE WAS REPLACED WITH SAME MODEL NEEDLE AND THE TRANSSEPTAL WAS COMPLETED. PROCEDURE OUTCOME WAS NOT DISCLOSED. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184949 ↗
• MalfunctionDec 7, 2023

  NRG TRANSEPTAL NEEDLE/BAYLIS NEEDLE WAS PLACED INTO AGILIS STEERABLE SHEATH. THE PHYSICIAN VERBALIZED THAT UPON ADVANCING THE BAYLIS INTO THE AGILIS, THAT HE WAS MET WITH AN ABNORMAL AMOUNT OF RESISTANCE. WHEN THE NEEDLE WAS REMOVED, THE NEEDLE WAS BENT/HAD A VISUAL ABNORMALITY. A SECOND AGILIS AND BAYLIS NEEDLE WAS OBTAINED AND THE SAME SCENARIO OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282107 ↗
• MalfunctionDec 7, 2023

  NRG TRANSEPTAL NEEDLE/BAYLIS NEEDLE WAS PLACED INTO AGILIS STEERABLE SHEATH. THE PHYSICIAN VERBALIZED THAT UPON ADVANCING THE BAYLIS INTO THE AGILIS THAT HE WAS MET WITH AN ABNORMAL AMOUNT OF RESISTANCE. WHEN THE NEEDLE WAS REMOVED, THE NEEDLE WAS BENT/HAD A VISUAL ABNORMALITY. A SECOND AGILIS AND BAYLIS NEEDLE WAS OBTAINED, AND THE SAME SCENARIO OCCURRED. THE NEEDLE DID NOT ENTER THE PATIENT'S BODY. THE SHEATH ENTERED THE PATIENT¿S BODY. THERE WAS NO HARM TO THE PATIENT. THERE WERE A TOTAL OF TWO AGILIS USES AND TWO BAYLIS NEEDLES. NRG TRANSEPTAL NEEDLE BAYLIS LARGE CURVE LOT #: NGFD310323.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282061 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, A NRG NEEDLE WAS SELECTED FOR USE. POST TRANSEPTAL PUNCTURE IT WAS DIFFICULT TO GET A NON-BOSTON SCIENTIFIC SHEATH ACROSS THE SEPTUM. ONCE THE SHEATH WAS ACROSS, THE STAFF PREPPED THE WATCHMAN ACCESS SHEATH FOR EXCHANGE AND DURING THIS TIME, LEFT SIDED ACCESS WAS LOST AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING NOTICED A NEW PERICARDIAL EFFUSION. THE PATIENT VITALS STARTED TO DECLINE, THE PROCEDURE WAS CANCELLED AND A PERICARDIOCENTESIS WAS PERFORMED. 150 ML OF BLOOD WERE DRAWN FROM THE PERICARDIAL SPACE, AND THE PATIENT'S VITALS RETURNED TO NORMAL AND BECAME STABLE. THE NEEDLE WAS DISPOSED.

  Patient problems: Pericardial Effusion

  MAUDE report 16809889 ↗
• MalfunctionApr 5, 2023Communication or Transmission Problem; Output below Specifications

  BAYLIS NRG NEEDLE WAS NOT RECEIVING THE RF ENERGY NEEDED TO BE GOING THROUGH IT TO GO TRANSSEPTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681214 ↗
• MalfunctionFeb 24, 2022Failure to Fire

  BAYLIS NEEDLE WOULD NOT FIRE DURING TRANSSEPTAL APPROACH. CABLE CHECKED; GROUNDING PAD CHECKED. UTILIZED ANOTHER NEEDLE W/O DIFFICULTY. NO HARM TO PT, PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590809 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE WAS USED IN A PROCEDURE IN WHICH A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN GAINED FEMORAL ACCESS ON THE PATIENT'S RIGHT AND LEFT SIDE. THE PHYSICIAN THEN INSERTED A ST. JUDE INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER TO VISUALIZE THE SEPTUM. THE PHYSICIAN INSERTED THE AGILIS GUIDEWIRE FOLLOWED BY THE AGILIS SHEATH. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND INSERTED THE NRG NEEDLE INTO THE AGILIS SHEATH. THE PHYSICIAN DROPPED DOWN FROM THE SUPERIOR VENA CAVA (SVC) INTO THE RIGHT ATRIUM (RA) AND VISUALIZED WHERE IT WAS BELIEVED THE NEEDLE WAS TENTING THE SEPTUM, AND ASKED THE NURSE TO OPERATE THE RFP-100A GENERATOR AT 1 SECOND OF RADIOFREQUENCY (RF) ENERGY ON CONSTANT MODE. THE PHYSICIAN WAS UNABLE TO CONFIRM IF CROSSING HAD OCCURRED SO THE NURSE WAS ASKED TO APPLY ANOTHER 1 SECOND OF RF ENERGY ON CONSTANT MODE. THE PHYSICIAN WAS UNABLE TO VISUALIZE IF THE LEFT ATRIUM HAD BEEN ACCESSED. THE PHYSICIAN THEN INJECTED CONTRAST AND SAW THE EFFUSION ON FLUOROSCOPY. THE PHYSICIAN VISUALIZED THE EFFUSION ON ICE AND WATCHED THE EFFUSION FOR THE NEXT SEVERAL MINUTES. THE PATIENT'S BLOOD PRESSURE REMAINED THE SAME AND THE EFFUSION SLOWLY SHRANK. THE PHYSICI

  Patient problems: Pericardial Effusion

  MAUDE report 9182673 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE WAS USED FOR TRANSSEPTAL PUNCTURE DURING A CRYO ABLATION PROCEDURE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. FOLLOWING TRANSSEPTAL PUNCTURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAPH WAS PERFORMED CONFIRMING AN EFFUSION. THE PATIENT WAS MONITORED AND TRANSFERRED TO THE INTENSIVE CARE UNIT AND NEO-SYNEPHRINE WAS ADMINISTERED. THE EFFUSION WAS LOCATED ON THE RIGHT LATERAL WALL OF THE RIGHT ATRIA. THE CAUSE OF THE EFFUSION WAS UNKNOWN. THE PATIENT WAS FOLLOWED AND STABILIZED. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 8454006 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE (NRG NEEDLE) AND TORFLEX TRANSSEPTAL GUIDING SHEATH (TFK) WERE USED FOR TRANSSEPTAL PUNCTURE IN A PROCEDURE. THE PHYSICIAN NOTICED AN EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOLLOWING THE FIRST AND DURING THE SECOND TRANSSEPTAL PUNCTURE. THE PHYSICIAN USED AN AGILIS SHEATH AND 98 CM C1 NRG NEEDLE TO PERFORM THE FIRST TRANSSEPTAL PUNCTURE. THE PHYSICIAN WAS ABLE TO PUNCTURE ACROSS THE SEPTUM EASILY IN A SAFE POSITION IN THE MIDDLE OF THE SEPTUM VIA ICE. THE PHYSICIAN THEN PREPARED FOR THE SECOND TRANSSEPTAL USING THE 45 DEGREE TFK AND 71 CM C1 NRG NEEDLE. THE PHYSICIAN HAD SOME DIFFICULTY GETTING INTO THE CORRECT POSITION AND WAS IN A VERY POSTERIOR AND LOW POSITION WITH THE SHEATH AND DILATOR. THE NRG NEEDLE WAS NEVER EXPOSED IN THIS POSITION. THE PHYSICIAN THEN TORQUED THE SHEATH AND NEEDLE INTO A BETTER TENTING POSITION AND APPLIED RF ENERGY FOR 1 SECOND (CONSTANT). BEFORE PUTTING ANYTHING ACROSS THE SEPTUM OTHER THAN THE NRG NEEDLE, THE PHYSICIAN SCANNED ICE AND NOTICED A LARGE EFFUSION DEVELOPING. THE PHYSICIAN MONITORED THE EFFUSION FOR A FEW MINUTES AND DECIDED IN CONSULTATION WITH ANOTHER PHYSICIAN THAT A PERICARDIAL TAP WAS REQUIRED. ONCE

  Patient problems: Pericardial Effusion

  MAUDE report 8454004 ↗