Medtronic Vascular recalls Valiant Navion Thoracic Stent Graft System (models VNMC2020C94TE, VNMC2020C94TJ, etc.) for endoleaks, stent fractures, and stent ring enlargement. Affected patients should contact Medtronic for evaluation.
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Medtronic is recalling its Valiant Navion Thoracic Stent Graft System for endovascular repair of descending thoracic aorta lesions. The recall is due to type IIIb endoleaks, stent fractures, and stent ring enlargement. Patients with the affected models should contact Medtronic for evaluation.
The device can develop type IIIb endoleaks, stent fractures, and stent ring enlargement. These issues may lead to complications such as device failure or the need for additional surgery, but the risk of serious injury is not explicitly stated in the recall.
Patients who have received the Valiant Navion Thoracic Stent Graft System for descending thoracic aorta repair are affected. Most at risk are those with the specific model numbers listed in the recall.
Check for model numbers starting with VNMC or VNMF followed by specific codes (e.g., VNMC2020C94TE, VNMF2020C96TE). Also check the GTIN numbers listed in the recall. Serial numbers are provided in the recall.
Review the model number on the device packaging or label to see if it matches the recalled models listed in the recall.
Reach out to Medtronic directly for evaluation and guidance on next steps if the device is affected.
It is used for endovascular repair of lesions in the descending thoracic aorta (DTA).
Check the model number on the device, which should start with VNMC or VNMF followed by specific codes (e.g., VNMC2020C94TE). Also, verify the GTIN or serial numbers listed in the recall.
The recall does not specify an immediate stop-use action; patients should contact Medtronic for evaluation.
We’ve drafted a message you can send Trsmima to request your refund or repair — edit it as you like.
Subject: Recall Z-1201-2021 — Trsmima Trsmima Hello, I own a Trsmima that is covered by recall Z-1201-2021 from Trsmima. 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.
