Boston Scientific and BD initiate venous stent recalls | 合法醫療器材資訊網

2021年5月28日—TheFDAannouncementregardingtheVicistentreadsthatBostonScientificinitiatedtherecallon12April“afterreportsindicatethatthestents ...

Boston Scientific and BD have both initiated recalls of venous stents. According to a US Food and Drug Administration (FDA) medical device recall notice posted 21 May, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and Vici RDS venous stent system. In a recall notification dated 12 May, BD announced that the company has expanded a safety notice issued earlier this year for the Venovo venous stent system.

The FDA announcement regarding the Vici stent reads that Boston Scientific initiated the recall on 12 April “after reports indicate that the stents may migrate or move from where they are initially implanted”. The FDA has labelled this a Class I recall.

Outlining the risks associated with stent migration, the statement reads: “A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, he...