Medtronic recalls Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch numbers that may detach during implant, requiring removal or leaving behind in patients.
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.
Medtronic is recalling Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch numbers that have a risk of the taper tip detaching during implant. This could require a secondary intervention to remove the tip or leave it behind in the patient.
The taper tip assembly in specific batches can detach during the implant procedure. If detached, it may require a second intervention to remove it via endovascular retrieval or surgery. In some cases, the tip may be intentionally left behind by the physician if not easily removable.
Patients who have received the recalled stent graft systems for infrarenal abdominal aortic or aortoiliac aneurysms using endovascular approaches are affected. Medical professionals performing the procedure are at highest risk.
Check the model/serial numbers listed in the recall notice. The affected products include Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch codes and serial numbers provided in the recall list.
Identify the model and serial numbers from the recall list to confirm if your device is affected.
Reach out to Medtronic directly for guidance on next steps if your device is listed in the recall.
The taper tip may detach during implant, requiring a second procedure to remove it or potentially being left behind in the patient.
Check the model and serial numbers against the list provided in the recall notice.
Yes, contact Medtronic to determine if your device is affected 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-0657-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0657-2022 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.
