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VENOUS WALLSTENT™

BOSTON SCIENTIFIC CORPORATION · Model H74912044169070 · UDI-DI 08714729979586

QAN Prescription

510(k) clearances

1,289

Adverse events (7 deaths)

Recalls

Facilities

Description

Self-Expanding Stent

Recalls

Date	Firm	Reason
2025-12-04	Medtronic Inc	Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
2024-02-16	Medtronic Inc.	There is a potential for sterile package breach.
2021-11-19	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	There have been reports of stent migration.
2021-04-12	Boston Scientific Corporation	The firm has received reports of stent migration after implantation
2021-04-12	Boston Scientific Corporation	The firm has received reports of stent migration after implantation
2021-03-16	Medtronic Inc.	Incorrect size printed on the device; packaging is labeled correctly.
2020-12-14	Bard Peripheral Vascular Inc	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
2020-12-14	Bard Peripheral Vascular Inc	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
2020-12-14	Bard Peripheral Vascular Inc	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

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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.