FDA Recall Open, Classified

Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE; ETBF2513C145EJ; ETBF2513C166E; ETBF2513C166EE; ETBF2513C166EJ; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C145EJ; ETBF2516C166E; ETBF2516C166EE; ETBF2516C166EJ; ETBF2813C124EE; ETBF2813C124EJ; ETBF2813C145E; ETBF2813C145EE; ETBF2813C145EJ; ETBF2813C166E; ETBF2813C166EE; ETBF2813C166EJ; ETBF2816C124EE; ETBF2816C124EJ; ETBF2816C145E; ETBF2816C145EE; ETBF2816C145EJ; ETBF2816C166E; ETBF2816C166EE; ETBF2816C166EJ; ETBF2820C124EE; ETBF2820C145EE; ETBF2820C145EJ; ETBF2820C166E; ETBF2820C166EE; ETBF2820C166EJ; ETBF3216C124E; ETBF3216C124EE; ETBF3216C124EJ; ETBF3216C145E; ETBF3216C145EE; ETBF3216C145EJ; ETBF3216C166EE; ETBF3216C166EJ; ETBF3220C124EE; ETBF3220C145EE; ETBF3220C166E; ETBF3220C166EE; ETBF3220C166EJ; ETBF3616C145E; ETBF3616C145EE; ETBF3616C145EJ; ETBF3616C166E; ETBF3616C166EE; ETBF3616C166EJ; ETBF3620C145EE; ETBF3620C166EE; ETBF3620C166EJ; ETCF2323C49E; ETCF2323C49EE; ETCF2525C49E; ETCF2525C49EE; ETCF2525C49EJ; ETCF2828C49E; ETCF2828C49EE; ETCF2828C49EJ; ETCF3232C49E; ETCF3232C49EE; ETCF3232C49EJ; ETCF3636C49E; ETCF3636C49EE; ETCF3636C49EJ; ETTF2323C70E; ETTF2323C70EE; ETTF2323C70EJ; ETTF2525C70E; ETTF2525C70EE; ETTF2525C70EJ; ETTF2828C70E; ETTF2828C70EE; ETTF2828C70EJ; ETTF3232C70E; ETTF3232C70EE; ETTF3232C70EJ; ETTF3636C70E; ETTF3636C70EE; ETTF3636C70EJ; ETUF2314C102E; ETUF2314C102EE; ETUF2314C102EJ; ETUF2514C102E; ETUF2514C102EE; ETUF2514C102EJ; ETUF2814C102E; ETUF2814C102EE; ETUF2814C102EJ; ETUF3214C102E; ETUF3214C102EE; ETUF3614C102E; ETUF3614C102EE; Medtronic Endurant IIs Stent Graft System Model/REF: ESBF2314C103E; ESBF2314C103EE; ESBF2314C103EJ; ESBF2514C103E; ESBF2514C103EE; ESBF2514C103EJ; ESBF2814C103E; ESBF2814C103EE; ESBF2814C103EJ; ESBF3214C103E; ESBF3214C103EE; ESBF3214C103EJ; ESBF3614C103E; ESBF3614C103EE; ESBF3614C103EJ; Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Recall: Z-0657-2022 · Initiated December 21, 2021

Recall

Recall Number: Z-0657-2022
Event Number: 89387
Firm: Medtronic Vascular, Inc.
FEI Number: 3005364322
Product Code: MIH
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: December 21, 2021
Address: 3850 Brickway Blvd, Santa Rosa, CA, 95403-8223

Description

Reason

Stent Graft Systems 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.

Action

Beginning 12/22/2021, the firm verbally communicated with Outside the Unites States customer and followed with a written begin on or about 01/19/2022 via regionally approved method. Beginning on 12/23/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-day delivery to U.S. customers informing them that a specific subset of stent graft systems may be susceptible to a delivery system component failure. Please note that this is a new recall and not related to any prior recalls performed on the delivery system (Event Numbers 88028, 88158 and 88951). For this recall, devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Customers are instructed to take the following actions: 1) Immediately identify and quarantine all unused affected devices listed in the enclosed Customer Detail Notification Report (on Table 1). 2) Return all unused affected devices to the Recalling Firm via your sales representative or by calling customer service at 1-888-283-7868 or email [email protected]. 3) Complete the enclosed Customer Confirmation Form and email to [email protected]. 4) Forward this notice to all those who need to be aware within their organization to include their physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, please forward this notice to those entities. For questions, please contact the Medtronic Field Representative or email [email protected]

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay and Viet Nam.

Quantity

14,629 devices