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pORTAL® EXT Extension Wire

PHENOX LIMITED · Model PORT-14-115-1-EX · UDI-DI 05391530910057

MOF Prescription

510(k) clearances

670

Adverse events (15 deaths)

Recalls

Facilities

Description

The pORTAL extension wire is intended to interface with pORTAL Neuro Wire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL Neuro Wire. This enables the usable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Neuro Wire.

Recalls

Date	Firm	Reason
2024-04-18	Stryker Neurovascular	Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire
2017-08-07	Microvention, Inc.	There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

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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.