Medtronic recalls Endurant II stent graft systems with specific model numbers due to risk of radiopaque marker detaching during deployment, potentially causing complications.
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Medtronic is recalling specific Endurant II stent graft systems because the radiopaque marker can detach during deployment. This could lead to complications if the marker becomes dislodged and is not properly visible during procedures.
During stent graft deployment, the radiopaque marker bond can detach from the distal end of the graft cover. This may cause the marker to become dislodged, making it difficult to track the device during procedures and potentially leading to complications.
Patients who have received the recalled Endurant II stent graft systems for abdominal aortic or aortoiliac aneurysms are affected. Medical professionals using these systems during procedures are at risk if the marker detaches.
Check for model numbers: ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, or ETUF3614C102E. These systems were sold with specific serial numbers listed in the recall notice.
Identify your stent graft system model number by checking the product label or documentation.
Reach out to Medtronic directly to confirm if your specific model is recalled and get instructions for next steps.
The recalled models are ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E.
The radiopaque marker bond can detach during deployment, potentially causing complications if the marker becomes dislodged and is not visible during procedures.
No, but you should contact Medtronic to confirm if your specific model is recalled and follow their instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2135-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
