Endurant Iis Stent Graft System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Endurant Iis Stent Graft System |
More than 10 numbers, contact manufacturer. |
ESBF3214C103EE, ESBF2314C103EE, ESBF2814C103EE, ESBF2514C103EE |
Endurant Ii Stent Graft System |
More than 10 numbers, contact manufacturer. |
ETCF2828C49EE, ETTF2323C70EE, ETBF2313C166EE, ETBF2513C145EE, ETBF2516C124EE, ETUF2814C102EE, ETBF2513C124EE, ETUF2514C102EE, ETBF2816C145EE, ETBF2813C124EE, ETCF2323C49EE, ETBF2516C166EE, ETBF2813C145EE, ETBF2813C166EE, ETBF2816C166EE, ETUF2314C102EE, ETBF2313C145EE, ETBF2316C166EE, ETBF2516C145EE, ETBF2820C145EE, ETCF2525C49EE, ETUF3614C102EE |
Issue
Devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable. As of 09-Dec-2021, Medtronic has received five (5) complaints where the taper tip detached from the delivery system during the procedure. In three (3) cases the tip was retrieved successfully: One (1) through surgical conversion and two (2) by snaring. in the remaining two (2) cases the tip was intentionally left behind. No deaths have been reported from the five (5) complaints.
Recall start date: Dec 23, 2021
Additional information
Details
| Medtronic Inc. |
|
710 Medtronic Parkway N.E., Minneapolis, Minnesota United States, 55432 |
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