FDA (Devices) recall action 74097
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Inability to deploy the stent or partial stent deployment.
The agency’s own wording, quoted from the enforcement report.
Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.
Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.