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pORTAL® Steerable Hydrophilic Guidewire

PHENOX LIMITED · Model PORT-14-200-1 · UDI-DI 05391530910040

MOF Prescription

510(k) clearances

670

Adverse events (15 deaths)

Recalls

Facilities

Description

The pORTAL Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guidewire provides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid the successful use of the device.

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.