Recall Z-0995-2020— W. L. Gore & Associates Inc.
Class II · Terminated
Class II FDA medical device recall by W. L. Gore & Associates Inc., initiated 2020-01-06, terminated 2022-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: GORE¿ EXCLUDER¿ AAA Endoprosthesis. Reason: Firm has received reports of leading end catheter component separations..
- Recalling firm
- W. L. Gore & Associates Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-06
- Terminated
- 2022-08-09
- Firm location
- Phoenix, AZ, United States
Product description
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Reason for recall
Firm has received reports of leading end catheter component separations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.