ClearanceBrief
Recall Z-1543-2017 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment

Medtronic Vascular, Inc.

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 endovasc

DateMar 15, 2017 (initiated Feb 27, 2017)
StatusTerminated
ReasonMedtronic 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.
Root causePackaging change control
ActionMedtronic sent an Urgent Medical Device Recall letter dated March 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received a potentially affected Endurant /Endurant II 23mm and / or 25mm Bifurcated Stent Graft System from the identified subset. As a result, Medtronic is asking that you take the following actions: Identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers th
Quantity3331 devices
DistributionWorldwide 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 Ger
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.