GORE EXCLUDER AAA Endoprosthesis
Recall
- Recall Number
- Z-0995-2020
- Event Number
- 84533
- Firm
- W. L. Gore & Associates Inc.
- FEI Number
- 3007284313
- Product Code
- MIH
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- January 6, 2020
- Terminated
- August 9, 2022
- Address
- 32360 N North Valley Pkwy, Phoenix, AZ, 85085-4228
Description
GORE EXCLUDER AAA Endoprosthesis
Firm has received reports of leading end catheter component separations.
The recall consists of corrections with no proposed product removal. The correction will consist of: A Medical Device Safety Correction letter sent to US physicians and hospitals and OUS hospitals and Distributors, along with an IFU Summary of Changes document Updates to the products Instruction for Use Updates to physician didactic training Additional manufacturing process error-proofing The firm is also instructing customers to share the letter with others in their hospital or clinic as appropriate, and contact the firm's Customer Service (email: [email protected] or by phone at 800-528- 8763) with any questions related to the letter. Any adverse event should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to Recalling Firm, email: [email protected] or contact: USA: +1.800.528.1866, Ext. 44922, +1.928.864.4922, Fax: +1.928.864.4364 China: +86 21 5172 8237, Fax: +86 21 5172 8236 Japan: +81 3 6746 2562, Fax: +81 3 6746 2563 Brazil: +55 11 5502-7953, Fax: +55 11 5502-7965 EMEA: +49 89 4612 3440, Fax: +49 89 4612 43440
US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;
255861 units