FDA Device Recall Z-1591-2021

Boston Scientific Corporation · Maple Grove, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

Lot / serial / GTIN: all batches/lots of the device manufactured between May 2018 through April 2021

Quantity: 550 units

Reason for recall

The firm has received reports of stent migration after implantation

Recall record

Recall number: Z-1591-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide - US Nationwide Distribution
Recall initiated: 2021-04-12
Classified by FDA Center: 2021-05-19
FDA published: 2021-05-26
Recalling firm: Boston Scientific Corporation
Firm location: Maple Grove, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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