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Philips issues Class I recall for Tack endovascular system - Interventional News

Summary by Interventional News

Philips has recently announced that it will no longer sell its Tack endovascular system in the USA following a Class I recall issued by the US Food and Drug Administration (FDA). A Class I recall is the FDA’s most serious classification, which denotes that the continued use of the affected product could result in severe injury or death. The FDA’s decision follows reports that the Tack endovascular system—designed to treat arterial dissections—ha…

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Endovascular Today

Philips Recalls, Removes, and Discontinues Distribution of Tack Endovascular System - Endovascular Today

March 6, 2025—The FDA advised this week that Philips is recalling the Tack endovascular systems because of challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant. The FDA recall notification advised that all customers should stop using the Tack endovascular system immediately and that Philips will no longer distribute the system for use. According to th…

27 days ago

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