FDA (Devices) recall action 84533
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.
Firm has received reports of leading end catheter component separations.
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.
W. L. Gore & Associates is recalling the GORE EXCLUDER Iliac Branch Endoprosthesis due to reports of leading end catheter component separations.
W. L. Gore & Associates is recalling GORE EXCLUDER AAA Endoprosthesis devices due to reports of leading end catheter component separations.