FDA (Devices) recall action 69025
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.
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.
St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.