Endurant II/IIs Stent Graft System: STENT GRAFT recall
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Why was Endurant II/IIs Stent Graft System: STENT GRAFT recalled?
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
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?
Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
- Product
- Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- 3 devices
- Distribution
- U.S. Nationwide distribution in the state of GA. O.U.S.: None
- Recall date
- July 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)