FDA (Devices) recall action 77529
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.
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
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.
Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with prosthetic valves.
Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.