AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # Lot/Serial 1164318 1164318019 1164390 1164390020 1164389 1164389009 1164388 1164388021 1262039 1262039002 1246596 1246596024 1164477 1164477026 1164470 1164470015 1055838 1055838026 1055838 1055838022 1250434 1250434002 1249743 1249743025 1257058 1257058017 1055877 1055877010 1249363 1249363009 1249358 1249358025 1267536 1267536008 1047170 1047170016 1267536 1267536025 1257553 1257553020 1214252 1214252011 1229346 1229346007 1274322 1274322003 1257977 1257977011 1250424 1250424016 1250424 1250424008 1250424 1250424007 1250399 1250399024 1047135 1047135007 1275167 1275167014 1275166 1275166031 1274322 1274322023 1250399 1250399011 1056308 1056308054
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Endologix
- Reason for Recall:
- Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Product Codes/Lot Numbers:
Lot # Lot/Serial 1164318 1164318019 1164390 1164390020 1164389 1164389009 1164388 1164388021 1262039 1262039002 1246596 1246596024 1164477 1164477026 1164470 1164470015 1055838 1055838026 1055838 1055838022 1250434 1250434002 1249743 1249743025 1257058 1257058017 1055877 1055877010 1249363 1249363009 1249358 1249358025 1267536 1267536008 1047170 1047170016 1267536 1267536025 1257553 1257553020 1214252 1214252011 1229346 1229346007 1274322 1274322003 1257977 1257977011 1250424 1250424016 1250424 1250424008 1250424 1250424007 1250399 1250399024 1047135 1047135007 1275167 1275167014 1275166 1275166031 1274322 1274322023 1250399 1250399011 1056308 1056308054
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1048-2017
Related Recalls
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.