Medtronic recalls Endurant IIs Stent Graft Systems with specific model numbers due to risk of radiopaque marker detachment during deployment, potentially affecting aneurysm treatment procedures.
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Medtronic is recalling two specific models of Endurant IIs Stent Graft Systems used for abdominal aortic aneurysm repairs. The recall is because a radiopaque marker can detach during deployment, which might cause imaging issues during surgery.
During stent graft deployment for abdominal aortic aneurysm repair, the radiopaque marker (used for X-ray visibility) can detach from the graft cover. This detachment might cause imaging errors during surgery, making it harder for doctors to track the device's position.
Patients who have received the Endurant IIs Stent Graft System with model numbers ESBF3214C103E or ESBF3614C103EE are affected. Medical professionals performing the procedure are most at risk due to potential imaging complications.
Check for model numbers ESBF3214C103E or ESBF3614C103EE on the product label. The system was sold with specific serial numbers listed in the recall notice.
Identify the model number on the device label to confirm if it matches ESBF3214C103E or ESBF3614C103EE.
The recall is because the radiopaque marker can detach during deployment, which might cause imaging issues during surgery.
Model numbers ESBF3214C103E and ESBF3614C103EE are affected, with specific serial numbers listed in the recall notice.
No action is required for the product itself; the recall is for identification and potential correction if needed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2136-2021 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.
