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EndoGI Specialized S-Path Delivery System

ENDO GI MEDICAL LTD · Model Delivery System · UDI-DI 00860005738243

FGE Prescription

510(k) clearances

33,832

Adverse events (359 deaths)

451

Recalls

148

Facilities

Description

The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent 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 Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).

Recalls

Date	Firm	Reason
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.
2026-05-21	Boston Scientific Corporation	Potential sterile breach of the pouches in which devices are packaged.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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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.