NRG Transseptal Needle NRG-E-HF-98-C1 (UDI 00685447004578)Recalls & 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
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447004578), received between Dec 3, 2024 and Dec 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. 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
- Display or Visual Feedback Problem1
Patient problems
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED A PERICARDIAL EFFUSION (PE) LEADING TO CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, TWO NRG TRANSSEPTAL NEEDLES AND A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. DURING TRANSEPTAL, THE PHYSICIAN STRUGGLED TO VISUALIZE A TENT ON THE FOSSA. THE FIRST ATTEMPT WAS WITH THE VERSACROSS CONNECT SYSTEM BUT WAS UNSUCCESSFUL. THEN, THE PHYSICIAN SWITCHED TO A NON-BOSTON SCIENTIFIC (SL0) SHEATH WITH NRG NEEDLE BUT IT WAS UNSUCCESSFUL AGAIN. A THIRD ATTEMPT WAS MADE WITH ANOTHER NON-BOSTON SCIENTIFIC (AGILIS) SHEATH WITH A NEW NRG NEEDLE. AT THIS TIME, AN EFFUSION WAS OBSERVED AROUND THE RIGHT ATRIUM (RA) OR RIGHT VENTRICULAR (RV). THE PHYSICIAN ABORTED THE CASE AND PROCEEDED TO TAP THE PATIENT. A DULL RED COLOR 545ML TOTAL REMOVED BUT 160ML GIVEN BACK TO PATIENT. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE AND WAS TO REMAIN OVERNIGHT FOR MONITORING. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. ELIQUIS WAS THE PATIENT OAC AND SHE WAS TO BE SWITCHED TO PLAVIX ASA PO
Patient problems: Cardiac Tamponade; Pericardial Effusion
MAUDE report 20834398 ↗
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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