NRG Transseptal NeedleRecalls & reported problems across all models

We found 4 models of NRG Transseptal Needle by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Sep 4, 2026 — classified as 3 deaths, 20 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NRG Transseptal Needle problems

NRG Transseptal Needle models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NRG Transseptal Needle NRG-E-HF-71-C0

  Catheter, Septostomy
  22 reports
• NRG Transseptal Needle NRG-E-HF-71-C1

  Catheter, Septostomy
  2 deaths17 reports
• NRG Transseptal Needle NRG-E-HF-98-C1

  Catheter, Septostomy
  1 death12 reports
• NRG Transseptal Needle NRG-E-HF-98-C0

  Catheter, Septostomy
  3 reports

Recent NRG Transseptal Needle adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

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

  It was reported that a patient death occurred.During a Faraview procedure, a NRG Transseptal Needle was selected for use. It was mentioned that the physician was only going to perform Pulmonary Vein Isolation and Posterior Wall Isolation with Farawave catheter. The patient was placed under general anesthesia. Physician started the punctures at around 6pm for the catheters and intracardiac echocardiography (ICE) catheter. Another physician was as performing transthoracic ultrasound during the whole length of the procedure. The doctors placed the Coronary Sinus catheter and proceeded to perform the transeptal puncture using NRG and Torflex. Ultrasound was performed to do the puncture and soon after, the RF was applied and the dilator was advanced. The Physician motioned that there was some fluid around the heart in the ultrasound. It was also mentioned that patient experienced a cardiac arrest. Pericardiocentesis was performed but the patient started to deteriorate. Patient coded and the doctors started performing CPR, called for the respiratory therapy specialists and a cardiac surgeon, who performed a thoracotomy but finally after 30min of CPR, blood transfusion, plasma, one cardio

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50600131 ↗
• MalfunctionAug 28, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508441 ↗
• MalfunctionAug 18, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310228 ↗
• 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 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC PERFORATION AND CARDIAC TAMPONADE OCCURRED. DURING A FARAPULSE ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN WAS INITIALLY AT WRONG POSITION AND HAD TO READJUST THE POSITION AND PERFORMED TRANSSEPTAL PUNCTURE (TSP). THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED TSP WENT GOOD WITHOUT TAMPONADE. THE PROCEDURE WAS COMPLETED HOWEVER AT THE END, THE PHYSICIAN NOTED IN THE ECHO A LARGE TAMPONADE IN RIGHT VENTRICULAR (RV) WALL. IT WAS NECESSARY TO DRAIN THE BLOOD FROM PERICARDIUM (350 ML). THE PATIENT REMAINED HOSPITALIZED. ACT WAS ABOVE 300. THE PERFORATION WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND THE SUSPICION IS THAT SOMETHING WENT WRONG DURING THE TRANSSEPTAL PUNCTURE PROCESS. PHYSICIAN TRIED TO DO THE TRANSSEPTAL ACCESS IN TWO PLACES. PHYSICIAN WAS NOT CONFIDENT THAT THE SYSTEM WAS IN A SECURE POSITION. THEREFORE, HE REPOSITIONED THE SYSTEM AFTER THE INITIAL ATTEMPT. AFTER THIS ATTEMPT, CHECKED THE PERICARDIUM USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND THE ECHOCARDIOGRAPHER REPORTED NO ISSUES. CARDIAC TAMPONADE WAS OBSERVED AFTER ALL CATHETERS WERE WITHDRAWN. THE DEVICE IS NOT EXPECTED TO B

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion; Pericarditis

  MAUDE report 24563849 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HEMATOMA OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PATIENT HAD A TORTUOUS GROIN. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC DILATOR WAS USED TO DILATE THE PATIENT'S VEIN. A NON-BSC SHEATH WITH NRG NEEDLE WERE USED. THE NEEDLE WAS USED TO CROSS THE SEPTUM WITH NO ISSUES WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPY GUIDANCE. AFTER CROSSING THE SEPTUM, THE WATCHMAN SHEATH WAS INSERTED. THE PATIENT'S BLOOD PRESSURE (BP) DROPPED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AFTER THE IMPLANT PROCEDURE. THE CT SHOWED A RETROPERITONEAL BLEED AT THE ILIAC. THE PATIENT WAS ADMITTED FOR OBSERVATION AND IS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED AND RECOVERED.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Retroperitoneal Hemorrhage

  MAUDE report 24401789 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYPOTENSION OCCURRED. IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. IT WAS NOTED THAT THE PATIENT BLOOD PRESSURE DROPPED PRIOR TO GETTING TRANSEPTAL ACCESS. THE PATIENT WAS TREATED WITH VASOPRESSORS AND BLOOD PRESSURE BACK TO NORMAL AFTER EXTUBATING. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT FOR OBSERVATION AND IS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT THE NRG WAS INSIDE THE BODY WHEN HYPOTENSION WAS NOTED. NO DIFFICULTY DURING TRANSSEPTAL WAS NOTED. THE PROCEDURE WAS RESUMED AFTER IT WAS TREATED. ACT WAS OVER 300-350. IN THE PHYSICIAN OPINION, THE DEVICE DID NOT CONTRIBUTE TO PATIENT COMPLICATION. THE PATIENT WAS DISCHARGED NEXT DAY WITH NO ISSUES.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24216026 ↗
• 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 ↗
• MalfunctionNov 24, 2025Failure to Deliver Energy; Off-Label Use; Failure to Advance; Failure to Deliver Energy; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE SELECTED FOR USE. DURING PROCEDURE, WHEN THE NRG NEEDLE WAS CONNECTED TO THE ELECTRICAL CONSOLE, A GENERIC ERROR MESSAGE APPEARED ON THE SCREEN OF THE BMC RF GENERATOR. AFTER PRESSING 'DISMISS,' THE DISPLAY INDICATED THAT THE PRODUCT WAS 'READY' FOR USE. AFTER THREE ATTEMPTS TO ACTIVATE THE RADIOFREQUENCY WITH THE SAME NEEDLE, THE TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE RADIO FREQUENCY WAS DELIVERED THE THREE TIMES, THE SOUND FOR IT WAS HEARD, BUT THE SEPTUM WAS NOT CROSSED. NO ERROR OCCURRED WHEN THE RF ENERGY WAS ACTIVATED. AN ERROR ONLY APPEARED WHEN THE FIRST NEEDLE WAS CONNECTED, THE CABLE WAS NOT REPLACED. THE SEPTUM WAS QUITE FLOPPY. GENERATOR WAS IN READY MODE WHEN THE ISSUE WAS ENCOUNTERED. NO CHALLENGES NOTED RELATED TO THE PATIENT ANATOMY. THERE WAS TENTING OF THE SEPTUM CONFIRMED BEFORE ATTEMPTING TO DELIVER RF ENERGY. THE FIRST NEEDLE WAS MANUALLY RESHAPED PRIOR TO THE PROCEDURE. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE PROCEEDED NORMALLY. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638650 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 19APR2025 IT WAS REPORTED AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN ELECTROPHYSIOLOGY PROCEDURE TO TREAT A CASE OF ATRIAL FIBRILLATION (A FIB). HOWEVER, UPON REMOVAL FROM THE PACKAGING IT WAS NOTED THAT THE NEEDLE HAD SIGNS OF DAMAGE/DEFECTIVENESS AND COULD THEREFORE NOT BE USED. THE PROCEDURE WAS INITIALLY HALTED AND EVENTUALLY COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE (SAME MODEL). NO PATIENT COMPLICATIONS REPORTED. THE PRODUCT HAS RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED THAT THE NRG NEEDLE TIP WAS BROKEN AND FULLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037063 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A NRG TRANSSEPTAL NEEDLE AND TORFLEX GUIDING SHEATH WAS SELECTED FOR USE. A J-TIP GUIDEWIRE WAS INSERTED INTO THE FEMORAL ACCESS TO THE SUPERIOR VENA CAVA (SVC). THE TORFLEX SHEATH WAS ADVANCED OVER THE WIRE AND THE GUIDEWIRE WAS EXCHANGED FOR THE NRG NEEDLE. THE PHYSICIAN DROPPED DOWN ONTO THE FOSSA USING STANDARD TRANSSEPTAL TECHNIQUE BUT FELL TOO LOW. HENCE, THE PHYSICIAN REQUESTED FOR THE GUIDEWIRE TO WIRE BACK AGAIN INTO THE SVC. THE RT HANDED A NON-BOSTON SCIENTIFIC PIGTAIL WIRE INSTEAD WHICH GOT STUCK IN TORFLEX DILATOR. THE PHYSICIAN PULLED OUT THE ENTIRE SYSTEM. SINCE THERE WAS NO NEW TORFLEX SHEATH, A NON-BOSTON SCIENTIFIC SHEATH WAS USED AS A REPLACEMENT. THE J-TIP RE-ADVANCED WITH THE SHEATH OVER IT, POSITIONED ONTO AN INFERIOR-POSTERIOR POSITION ON THE SEPTUM. THE RADIO FREQUENCY WAS DELIVERED USING NRG AND THE TRANSSEPTAL WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN SWAPPED OUT THE NEEDLE FOR THE NON-BOSTON SCIENTIFIC WIRE AND NOTICED THAT IT ADVANCED IN A STRANGE POSITION ON FLUORO AND PULLED BACK. IT WAS THEN RE-ADVANCED INTO T

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20621252 ↗
• 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 ↗
• MalfunctionJun 25, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR A PULSE FIELD ABLATION CASE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHILE TRYING TO GO TRANSSEPTAL, THE NRG RF NEEDLE WAS UNABLE TO CROSS THE SEPTUM. THREE ATTEMPTS TO DELIVER RADIO FREQUENCY WERE DONE, WITH NO SUCCESS. THEREFORE, THE DEVICE WAS PULLED OUT FOUND TO HAVE ITS TIP BROKEN. THE DEVICE WAS THEN REPLACED, TRANSSEPTAL PUNCTURE WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT RETURN FOR ANALYSIS. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608278 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. A PERFORATION WAS REPORTED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LAAC PROCEDURE, WHILE ATTEMPTING THE TRANSSEPTAL PUNCTURE, THE NRG NEEDLE PUNCTURED THE AORTIC ROOT. THE SET UP FOR TRANSSEPTAL WAS NORMAL FLOW, AND THE PHYSICIAN SAW A VISIBLE TENT IN THE SEPTUM BEFORE APPLY ENERGY TO THE NRG. AFTER ENTRY WAS APPLIED THE AIR/BUBBLE ARTIFACT WAS APPARENT IN THE AORTA, MAINTAINED POSITION AND CALLED FOR SURGICAL BACKUP. THUS, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS HEMODYNAMICALLY STABLE, AND WAS TAKEN TO THE SURGERY ROOM FOR REPAIR. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND PATIENT DID GOOD, AND IT HAS BEEN DISCHARGED. IT WAS FURTHER CONFIRMED THAT NO PERFORATION NOR PERICARDIAL EFFUSION WAS NOTED PRIOR TO PROCEDURE. ALSO, THERE WERE MULTIPLE PACEMAKER WIRES TO WORK AROUND TO GET TO SEPTUM. NO MALFUNCTIONS NOTED WITH THE DEVICE. IN THE PHYSICIAN'S OPINION, THE NRG NEEDLE HAS CONTRIBUTED TO THE PERFORATION, DUE TO ITS USAGE.

  Patient problems: Perforation of Vessels

  MAUDE report 19255749 ↗
• MalfunctionApr 23, 2024Material Integrity Problem; Material Integrity Problem

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN UNKNOWN PROCEDURE. IT WAS MENTIONED THAT THE NEEDLE WAS BROKEN/SNAPPED BEFORE USING OR TOUCHING IT. PROCEDURE OUTCOME WAS NOT PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164335 ↗

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