Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C

FDA device recall Z-1543-2017 · posted 2017-03-15 · Terminated

Recall details

Recalling firm

Medtronic Vascular, Inc.

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.

Action taken

Medtronic 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 that are in your inventory . Return unused products from the attached model and serial number list that are in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 (#4) and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of this product as necessary. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For further questions please call Customer Service at 1 (800) 633-8766.

Root cause

Packaging change control

Status

Terminated

Product code

MIH

Quantity affected

3331 devices

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 Cze

Date initiated

2017-02-27

Date posted

2017-03-15

Date terminated

2018-03-01

Location

Santa Rosa, CA