NRG Transseptal Needle NRG-71-C0Recalls & reported problems
Baylis Médicale Cie Inc · Class 2
All models of NRG Transseptal Needle (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447004332), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 death.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 27, 2026Adverse Event Without Identified Device or Use Problem
A CARDIAC ARREST OCCURRED AND THE PATIENT PASSED AWAY. IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE DURING A CONCOMITANT PULSED FIELD ABLATION (PFA) AND THEN WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB). FOLLOWING COMPLETION OF THE PROCEDURE, ALL PRODUCTS WERE REMOVED FROM THE PATIENT. A NON-BOSTON SCIENTIFIC DEVICE WAS REQUESTED AND THE PATIENT WAS PREPARED FOR THE USE OF IT. ONCE TRANSSEPTAL WAS ACHIEVED, A NON-BOSTON SCIENTIFIC SHEATH WAS EXCHANGED FOR A NON-BOSTON SCIENTIFIC DELIVERY SHEATH. A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS INSERTED, AND THE PATIENT BLOOD PRESSURE DROPPED. A CARDIAC ARREST WAS REPORTED. A CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTRATED WHEN PACING COULD NOT BE CAPTURED. AFTER SEVERAL MINUTES OF ATTEMPTED TO STABILIZE THE PATIENT, A CORONARY ANGIOGRAPHY WAS PERFORMED. A NON-BOSTON SCIENTIFIC DEVICE WAS PLACED INTO THE PATIENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD COURSE OF CARE. THE WATCHMAN PROCEDURE WAS ABORTED. THE NRG NEEDLE WAS NOT IN THE BODY AT THE TIME OF THE ISSUE HAPPENED, AND ACCORDING TO THE PHYSICIAN, THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. LATER, IT WAS REPORTED THAT THE
Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension
MAUDE report 24193445 ↗
Other Catheter, Septostomy devices
- VersaCross Access Solution VXSK0031Baylis Médicale Cie Inc · Catheter, Septostomy1 recall16 reports
- VersaCross Access Solution VXSK0021Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 death15 reports
- VersaCross Access Solution VXSK0032Baylis Médicale Cie Inc · Catheter, Septostomy1 recall14 reports
- VersaCross Access Solution VXSK0022Baylis Médicale Cie Inc · Catheter, Septostomy1 recall13 reports
- VersaCross Access Solution VXSK0024Baylis Médicale Cie Inc · Catheter, Septostomy1 recall3 reports
- VersaCross Access Solution VXSK0025Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- VersaCross Access Solution VXSK0034Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- NRG Transseptal Needle NRG-E-HF-71-C0Boston Scientific Corporation · Catheter, Septostomy22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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