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Single Use Biliary Drainage Stent V

OLYMPUS MEDICAL SYSTEMS CORP. · Model PBD-1031-1005 · UDI-DI 04953170460067

FGE Prescription

510(k) clearances

33,832

Adverse events (359 deaths)

453

Recalls

149

Facilities

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.