Overview of recall records associated with W.L. Gore & Associates, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 30.
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being…
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
The incorrect label was placed on both the primary and secondary package.
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Firm has received reports of leading end catheter component separations.
Firm has received reports of leading end catheter component separations.
This page summarizes recall records in which the official source identifies W.L. Gore & Associates, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
