FDA Device recall Z-1543-2017
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E…
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E… by Medtronic Vascular, citing medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1543-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-27 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Vascular |
| Distribution | PR |
Product
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Reason
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Identifiers
| code_info | Product UPN/GTIN Serial number 00613994992048 V05884896 00643169215849 V05981026 00643169215849 V05981027 006431692…Product UPN/GTIN Serial number 00613994992048 V05884896 00643169215849 V05981026 00643169215849 V05981027 00643169215849 V05981030 00643169215849 V05981031 00643169215849 V05981032 00643169215849 V05981033 00643169215849 V05981034 00643169215849 V05981035 00613994992024 V05981039 00613994992024 V05981040 00613994992024 V05981044 00613994992024 V05981045 00643169215856 V05981415 00643169215856 V05981416 00643169215856 V05981417 00643169215856 V05981418 00643169215856 V05981419 00643169215856 V05981420 00643169215856 V05981421 00643169215856 V05981422 00643169215856 V05981423 00643169215856 V05981424 00613994991263 V05981721 00613994991263 V05981722 00613994991263 V05981723 00613994991263 V05981724 00613994991263 V05981725 00613994991263 V05981726 00613994991263 V05981728 00643169215795 V05982579 00643169215795 V05982581 00643169215795 V05982584 00643169215795 V05982586 00613994992048 V05983552 00613994992048 V05983556 00613994992048 V05983558 006139 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1543-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.