Home › ENDO GI MEDICAL LTD › X-Path Pre-loaded RX-OTW Double Biliary Stents System

X-Path Pre-loaded RX-OTW Double Biliary Stents System

ENDO GI MEDICAL LTD · Model Double-Stent · UDI-DI 00860005738205

FGE Prescription

510(k) clearances

34,031

Adverse events (362 deaths)

453

Recalls

149

Facilities

Description

The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.

Recalls

Date	Firm	Reason
2026-09-10	Boston Scientific Corporation	Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
2026-09-03	W L Gore & Associates, Inc.	The potential for the devices to be mislabeled with the incorrect length.
2026-08-19	Olympus Corporation of the Americas	Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
2026-05-22	W L Gore & Associates, Inc.	10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
2026-05-22	W L Gore & Associates, Inc.	10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.

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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.