Medtronic recalls Endurant II stent grafts with incorrect stentstop assembly (18fr) that could cause device malfunction during vascular aneurysm treatment.
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Medtronic is recalling Endurant II stent grafts with an incorrect stentstop assembly (18fr) that could malfunction during vascular aneurysm treatment. This recall affects specific model numbers and serial numbers listed in the notice.
The device uses an incorrect stentstop assembly (18fr) instead of the required 20fr. This mismatch could cause the delivery system to malfunction during vascular aneurysm treatment, potentially leading to improper device deployment.
Patients who received the Endurant II stent graft system with model number ETBF3216C145E and serial numbers V30064787, V30064789, or V30064790 are affected. Medical professionals using this specific device for vascular aneurysm treatment are at risk.
Check for model number ETBF3216C145E and serial numbers V30064787, V30064789, or V30064790 on the device packaging or documentation. This recall applies to specific units sold for vascular aneurysm treatment.
Verify the model number (ETBF3216C145E) and serial numbers (V30064787, V30064789, V30064790) on the device packaging or documentation.
The recall is due to an incorrect stentstop assembly (18fr) used instead of the required 20fr, which could cause device malfunction during vascular aneurysm treatment.
Model number ETBF3216C145E with serial numbers V30064787, V30064789, and V30064790.
The recall does not require immediate discontinuation; affected users should check device details and contact Medtronic for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1976-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1976-2021 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.
