Recalls Initiated for Boston Scientific’s Vici and BD’s Venovo Venous Stents

May 26, 2021—Device recalls of venous stents were recently initiated by Boston Scientific Corporation and Bard Peripheral Vascular, Inc., a wholly owned subsidiary of Becton, Dickinson and Company (BD).

Boston Scientific recalled the Vici venous stent system and Vici RDS venous stent system. BD expanded the scope of its earlier safety notice of the Venovo venous stent system.

On May 21, the FDA posted its notification identifying a Class 1 recall of Boston Scientific’s Vici and Vici RDS venous stent systems, which are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. The FDA notification is available online.

The FDA assigned the Class I identification because of the potential of stent migration. A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient. If the stent migrates to the heart, it could cause life-threatening injury. There have been 17 complaints and reported injuries related to this issue. No deaths have been reported.

Boston Scientific recalled the Vici and Vici RDS devices on April 12 with an Urgent Medical Device Recall Notification to customers asking them to: immediately discontinue use of the device; remove all affected units from inventory and secure them; complete the company’s Verification Form to acknowledge receipt and report products that will be returned; and package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. More information is available on the FDA Medical Device Recall Database Entry, which provides the models and serial numbers of the effected devices that were distributed from September 21, 2018 through April 9, 2021.

On May 12, BD announced it expanded the scope of the Urgent Medical Device Safety Notice for the Venovo venous stent system to include all sizes and lots within expiry date. As previously communicated in the Safety Notice of January 13, 2021, BD received reports on the Venovo device indicating that the proximal end of the stent does not immediately expand upon deployment but remains connected to the stent cushion on the delivery system. The Customer Letter provided an illustration of the proximal section adhering to the stent cushion.

According to the company notice, if the proximal end of the stent does not immediately expand upon deployment, over-manipulation or forcing the catheter delivery system as well as use of other intravascular devices or techniques to assist the stent’s expansion, could potentially have a varying degree of harm associated with it. This issue was initially observed on the 14-mm diameter device. After the issuance of the safety notice, there have been reported complaints across other sizes of the product offering. To date, BD has received approximately 250 reported complaints across various sizes of the product offering, advised the company notice.