NRG Transseptal Needle NRG-E-HF-98-C0 (UDI 00685447004561)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 00685447004561), received between Aug 1, 2025 and Aug 1, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning 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
- Positioning Problem1
Patient problems
- Cardiac Perforation1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2025Positioning Problem; Positioning Problem
IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A FARAPULSE ABLATION OF ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO PERFORM THE TRANSSEPTAL PUNCTURE (TSP) WITH THE FARADRIVE AND THE NRG NEEDLE. AFTER TENTING THE NEEDLE, THE PHYSICIAN KEPT MOVING THE NEEDLE INSIDE THE PATIENT. AFTER A FEW POSITIONING IN THE LEFT ATRIUM, IT WAS NOTED THAT SOME OF THE CONTRAST WAS OUTSIDE OF THE HEART SILHOUETTE. THE SYSTEM WAS WITHDRAWN AND PERFORMED THE TRANSSEPTAL WITH A NON-BOSTON SCIENTIFIC TRANSSEPTAL DEVICE. AFTER THE PROCEDURE, THE ECHO PHYSICIAN CONFIRMED A DISCREET PERICARDIAL EFFUSION. THE EFFUSION WAS DRAINED IT AND THE PATIENT HAD NO OTHER PROBLEM. THE PATIENT WAS FULLY RECOVERED. IN THE PHYSICIAN'S OPINION, THE NRG NEEDLE DID NOT CONTRIBUTE TO THE EVENT, IT WAS THE FARADRIVE DILATOR THAT MAY HAVE CONTRIBUTED TO IT. THE PATIENT HAS A RELATIVE SMALL RIGHT ATRIUM AND MOVING IT TRYING TO POSITION THE SHEATH IN THE FOSSA WAS THE MAIN CAUSE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER CONFIRMED THAT THE PATIENT HAS BEEN DISCHARGED IN THE NEXT DAY AFTER FULL EP PROCEDURE PROTOCOL
Patient problems: Cardiac Perforation; Pericardial Effusion
MAUDE report 22688662 ↗
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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