Recall Z-1048-2017— Endologix
Class II · Terminated
Class II FDA medical device recall by Endologix, initiated 2017-01-04, terminated 2017-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment..
- Recalling firm
- Endologix
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-04
- Terminated
- 2017-04-28
- Firm location
- Irvine, CA, United States
Product 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
Reason for recall
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.