GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reported: February 12, 2020 Initiated: January 6, 2020 #Z-0996-2020
Product Description
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reason for Recall
Firm has received reports of leading end catheter component separations.
Details
- Recalling Firm
- W. L. Gore & Associates Inc.
- Units Affected
- 23212 units
- Distribution
- 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;
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE). Recalled by W. L. Gore & Associates Inc.. Units affected: 23212 units.
Why was this product recalled? ▼
Firm has received reports of leading end catheter component separations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0996-2020.
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