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 s
Check against the official notice below — it lists the full affected range.
Medtronic is voluntarily recalling specific models and serial numbers of Endurant and Endurant II Bifurcated Stent Graft Systems (23mm and 25mm sizes). The recalled devices have greater susceptibility to fabric permeability variations that may be associated with endoleaks, which are leaks that can occur during the initial implant procedure. Approximately 3,331 devices are affected by this recall and were distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries across multiple continents.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhs Quantity: 3331 devices Lot/code info: 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 00613994991980 V05984180 00613994991980 V05984181 00613994991980 V05984182 00613994991980 V05984183 00613994991980 V05984184 00613994991980 V05984185 00613994991980 V05984186 00613994991980 V05984187 00613994991980 V05984188 00613994991980 V05984189 00613994992031 V05985031 00613994992048 V05985511 00613994992048 V05985512 00613994992048 V05985513 00613994992048 V05985514 00613994992048 V05985515 00613994992048 V05985516 00613994992048 V05985517 00613994992048 V05985518 00613994992048 V05985519 00613994992048 V05985520 00613994992048 V059
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.