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NRG RF Transseptal Kit

Baylis Médicale Cie Inc · Model NTK-P711-8545S · UDI-DI 00685447014010

DXF DQY DRE DYB Prescription

510(k) clearances

2,144

Adverse events (104 deaths)

Recalls

Facilities

Description

1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire

Recalls

Date	Firm	Reason
2025-06-10	Boston Scientific Corporation	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca
2025-06-10	Boston Scientific Corporation	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca
2025-06-10	Boston Scientific Corporation	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca
2025-06-10	Boston Scientific Corporation	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca
2020-08-25	Medtronic Vascular	Subsequent failure of catheters in the field and failed quality testing
2020-08-25	Medtronic Vascular	Subsequent failure of catheters in the field and failed quality testing
2020-08-25	Medtronic Vascular	Subsequent failure of catheters in the field and failed quality testing
2019-03-28	Edwards Lifesciences, LLC	Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
2019-03-28	Edwards Lifesciences, LLC	Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
2016-10-11	Baylis Medical Corp *	The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transse

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.