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Syntel® Biliary Catheters

APPLIED MEDICAL RESOURCES CORPORATION · Model A4754 · UDI-DI 00607915110994

FGE Prescription

510(k) clearances

34,031

Adverse events (362 deaths)

453

Recalls

149

Facilities

Description

Used for the removal of stones and ductal debris from the biliary system.

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.