Medtronic recalls Endurant II Stent Graft Systems with specific model numbers due to risk of spindle detaching during deployment, which could cause complications. Affected units include ETBF2513C145EE and other variants listed in the recall.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Medtronic is recalling Endurant II Stent Graft Systems with certain model numbers because during deployment, the spindle may detach from the distal end of the hypotube. This could lead to complications during vascular procedures. Affected units have specific model numbers listed in the recall.
The hazard occurs during stent graft deployment when the spindle may detach from the distal end of the hypotube. This could lead to complications during vascular procedures if the spindle becomes dislodged.
Patients undergoing vascular procedures who have the Endurant II Stent Graft System with the listed model numbers are at risk. The recall affects specific variants used in medical procedures.
Check the model number on the product, which includes variants like ETBF2513C145EE, ETBF2820C166EE, and others listed in the recall. The product also has specific serial numbers associated with the recall.
Look for the model number on the product, such as ETBF2513C145EE or ETBF2820C166EE, which are listed in the recall.
The recall includes specific model numbers like ETBF2513C145EE, ETBF2820C166EE, and others listed in the product description.
Check the model number on the product, which is listed in the recall. Affected units have specific model numbers such as ETBF2513C145EE and others.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0291-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0291-2022 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.
