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HOTWIRE™ RF GUIDEWIRE

Atraverse Medical, Inc · Model 902034 · UDI-DI 00850057445596

DXF Prescription

510(k) clearances

2,144

Adverse events (104 deaths)

Recalls

Facilities

Description

The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ is intended to be used in conjunction with compatible previously cleared intravascular sheaths and/or dilators, and with the HOTWIRE™ System RF Generator. The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and provides fluoroscopic and/or echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for connection to the included Handpiece, which connects to the Hotwire System RF Generator.

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.