AFX Endovascular AAA System recall
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…
Why was AFX Endovascular AAA System recalled?
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Endologix
- Quantity
- 34 units
- Distribution
- Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand.
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)