Medtronic recalls Endurant IIs Stent Graft System with serial numbers starting with ESBF2814C103EE due to potential spindle detachment during deployment, which could cause complications. Affected units include specific model numbers and serial ranges.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Medtronic is recalling Endurant IIs Stent Graft Systems with specific model numbers (ESBF2814C103EE) because the spindle may detach during deployment. This could lead to complications during medical procedures. Affected units have serial numbers listed in the recall notice.
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. This could cause the device to malfunction or move unexpectedly during medical procedures, potentially leading to complications.
Patients who have received the Endurant IIs Stent Graft System with model number ESBF2814C103EE are most at risk. Medical professionals using the device during procedures may also be affected.
Check for model number ESBF2814C103EE on the device packaging or label. Affected units have specific serial numbers listed in the recall notice, including ranges like V30609409 to V30629773.
Look for the serial number on the device packaging or label to confirm if it's in the affected range.
Reach out to Medtronic directly for further instructions if your device is affected.
The affected model number is ESBF2814C103EE. Specific serial numbers are listed in the recall notice.
Check the serial number on your device packaging or label. Affected units have serial numbers starting with V30609409 and ending with V30629773.
No, but you should check if your device is affected and contact Medtronic for instructions if it is.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0292-2022 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-0292-2022 from Medtronic Vascular. 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.
