NRG Transseptal Needle NRG-E-HF-71-C0 (UDI 00685447004523)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00685447004523), received between Feb 7, 2023 and May 7, 2025 — classified as 6 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE (TSP). SHORTLY AFTER THE TSP AND PRIOR TO INSERTION OF THE FARADRIVE, THERE WAS A SUDDEN DROP IN THE BLOOD PRESSURE. THE PHYSICIAN DID NOT SEE AN EFFUSION, AND NOTED NORMAL LEFT ATRIUM PRESSURES AFTER CROSSING. THE CASE WAS ABORTED DUE TO A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE AND THE PATIENT WAS SENT FOR A CHEST COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). CT INITIALLY SHOWED CONSOLIDATION OF THE LEFT LUNG. HYPOTENSION WAS TREATED WITH CALCIUM, ADRENALINE, PHENYLEPHRINE, VASOPRESSIN, SODIUM BICARBONATE. THE PATIENT HAS HAD A PREVIOUS ATTEMPT AT ABLATION AND HAD THE SAME RESPONSE FOLLOWING TRANSSEPTAL. THE PHYSICIAN BELIEVES THIS IS RELATED TO THE PROCEDURE, BUT NOT TO THE NRG NEEDLE PRODUCT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21977565 ↗
• InjuryApr 2, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED PATIENT EXPERIENCED PERICARDIAL AFFUSION AND CARDIAC TAMPONADE. DURING A CONCOMITANT PULSE FIELD ABLATION (PFA) AND WATCHMAN PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PATIENT HAD COMPLICATED ANATOMY DUE TO KYPHOSIS. THE PHYSICIAN HAD DIFFICULTY PERFORMING TRANSEPTAL PUNCTURE DUE TO ANATOMY. POST TRANSSEPTAL, THE PATIENT MAINTAINED BASELINE HEMODYNAMICS. A NON-BOSTON SCIENTIFIC PFA CATHETER INSERTED, AND ABLATION WAS PERFORMED. UPON REMOVAL OF ABLATION CATHETER, IMAGING PHYSICIAN NOTICED A MODERATE SIZED EFFUSION ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A WATCHMAN DEVICE DEPLOYED SUCCESSFULLY. A PERICARDIOCENTESIS WAS PERFORMED POST SUCCESSFUL IMPLANT. LATER, THE PATIENT UNDERWENT SURGERY AND WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2025. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PHYSICIAN BELIEVES THAT MAYBE THE EVENT OCCURRED WHILE TRYING TO GAIN TRANSEPTAL ACCESS.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21753457 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBUS WAS NOTED AND THE PROCEDURE WAS CANCELLED. IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC). DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY SAW WHAT APPEARED TO BE SOME HEAVY SLUSH IN THE LEFT ATRIAL APPENDAGE WHEN TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED. THEY DECIDED TO PROCEED WITH THEIR TRANSSEPTAL WORKFLOW USING THE NRG NEEDLE AND AN SL0 SHEATH. AS SOON AS TRANSSEPTAL ACCESS WAS ACHIEVED AND THEY GOT ACCESS TO THE LEFT ATRIUM (LA), THE SLUSH THAT WAS NOTED EARLIER BECAME A CLOT, AND THE PHYSICIANS DECIDED TO ABORT THE PROCEDURE. THERE WERE NO CHANGES IN THE PATIENT'S VITALS, THE PATIENT REMAINED STABLE THROUGH THE ENTIRE PROCEDURE. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT HAS BEEN FURTHER MENTIONED THAT NO CLOT WAS SEEN ON ANY OF THE PRODUCTS. THE PHYSICIAN DOES NOT BELIEVE THAT THE NRG NEEDLE CONTRIBUTED TO THE CLOT. THE THROMBUS SEEN ON THE LEFT SIDE OF THE HEART. NO ACTION TAKEN TO ADDRESS THE THROMBUS DUE TO ACT BEING HIGH. NO FURTHER INFORMATION ABOUT THE PATIENT WAS DISCLOSED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21599238 ↗
• InjuryMar 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A PERFORATION OCCURRED, LEADING TO A PERICARDIAL EFFUSION (PE), AND THE PROCEDURE WAS CANCELLED. IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT THE PHYSICIAN WAS FAR TOO POSTERIOR WHEN ATTEMPTING TRANSSEPTAL TO REMAIN SAFE FROM THE AORTA. THE RADIOFREQUENCY (RF) WAS THEN TURNED ON, BUT IT WAS HARD TO SEE THE BUBBLES ON ECHO, THEREFORE, A SECOND ATTEMPT WAS PERFORMED. CONSEQUENTLY, IT WAS NOTED THAT THE DEVICES PERFORATED THROUGH THE BACK WALL. THE PHYSICIAN NOTICED THAT THE GUIDEWIRE WAS GOING AROUND THE HEART ON FLUOROSCOPY IN UNEXPECTED WAY. THEY THEN ADVANCED THE TRUSTEER DILATOR AND SHEATH TO THE LEFT SIDE AND SWITCHED OUT THE GUIDEWIRE FOR A 6F PIGTAIL TO SHOOT CONTRAST. ONCE THEY SHOT CONTRAST INTO THE HEART, THE USER NOTICED IT WAS GOING AROUND THE PERICARDIUM. AT THIS POINT, THE PHYSICIAN BEGAN ASPIRATING BLOOD OUT OF THE PERICARDIUM. THE PERICARDIAL EFFUSION (PE) WAS SAID TO HAVE REMAINED "MILD" AND WAS MONITORED FOR 20-25 MINUTES BEFORE SENDING THE PATIENT TO THE INTENSIVE CARE UNIT (ICU). PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IN THE PHYSICIAN'S OPINION, IT

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 21586831 ↗
• MalfunctionJan 8, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED DURING AN ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. WHEN THE PHYSICIAN WENT TO APPLY RADIO FREQUENCY (RF) VIA NRG ON THE SEPTUM TO GO TRANSSEPTAL, THE RF WAS APPEARING TO HAVE DELIVERED BUT ACCESS TO THE LEFT ATRIUM (LA) WAS NOT GAINED. THE TIP OF THE NRG NEEDLE WAS CONFIRMED TO BE EXTENDED PAST THE SHEATH. THE ONE SECOND CONSTANT PARAMETER WAS USED ON THE GENERATOR AND THERE WERE NO ERRORS WHEN THE RF BUTTON WAS PRESSED. THE PHYSICIAN TRIED REPOSITIONING AND REDELIVERING RF A FEW MORE TIMES BUT ISSUE PERSISTED. THUS, THE PHYSICIAN REQUESTED A NEW NRG NEEDLE. WITH THE NEW NRG NEEDLE, RF WAS DELIVERED WITH THE SAME PARAMETERS, AND GAINED ACCESS INTO THE LA ON THE FIRST TRY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105114 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION PROCEDURE INDICATED FOR A CASE OF PAROXYSMAL ATRIAL FIBRILLATION, A VERSACROSS ACCESS SOLUTION KIT AND A NRG RF NEEDLE WERE SELECTED FOR USE. THE PHYSICIAN GOT PLACEMENT IN FOSSA AND ATTEMPTED TO CROSS SEPTUM WITH VERSACROSS RF WIRE THREE TIMES. THEN, INCREASED TO TWO SECONDS CONSTANT HOWEVER WAS STILL UNABLE TO CROSS TRANSEPTAL. HENCE, TRANSEPTAL WAS OBTAINED USING A NRG TRANSSEPTAL NEEDLE AND TORFLEX SHEATH BUT LATER A PERICARDIAL EFFUSION WAS DISCOVERED AND REQUIRED A PERICARDIOCENTESIS. THE PROCEDURE WAS CANCELLED. THE NRG NEEDLE AND VERSACROSS RETURN ARE EXPECTED. IN THE PHYSICIAN OPINION, SINCE HE COULD NOT CROSS WITH VERSACROSS AND CHANGED TO NRG FIRST TIME TO CROSS SEPTUM AND PE DEVELOPED, HE FELT THE NRG MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS FURTHER CONFIRMED FLUOROSCOPY AND ICE WERE USED FOR VISUALIZATION. IT WAS ATTEMPTED TO CROSS WITH VERSACROSS FOUR TIMES, THE VERSACROSS RF WIRE WAS PROTRUDING OUT OF THE DILATOR WHEN ATTEMPTING TO CROSS AND SLIGHT FORWARD PRESSURE WAS APPLIED UPON FOURTH ATTEMPT TO CROSS. TENTING WAS SEEN MID ANTERIOR ON THE FOSS

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21001980 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BRADYCARDIA REQUIRING SURGICAL INTERVENTION OCCURRED DURING A PROCEDURE IN WHICH THE NRG TRANSSEPTAL NEEDLE WAS USED. DURING THE TRANSSEPTAL PROCEDURE, THE PHYSICIAN HIT A NODE ON THE RIGHT SIDE OF THE HEART RESULTING IN SEVERE BRADYCARDIA. THE PATIENT REQUIRED PACING FOR APPROXIMATELY 5 MINUTES AFTER WHICH NORMAL RHYTHM RETURNED AND THE TRANSSEPTAL PROCEDURE WAS COMPLETED SUCCESSFULLY. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT FOR THE NRG TRANSSEPTAL NEEDLE.

  Patient problems: Bradycardia

  MAUDE report 16315170 ↗