Medtronic recalls Affinity NT Cardiotomy/Venous Reservoir with Filter for possible sterile barrier breach in the pouch, risking infection during surgery. Affected units were sold for cardiac procedures.
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
Medtronic is recalling its Affinity NT Cardiotomy/Venous Reservoir with Filter for a possible sterile barrier breach in the pouch. This could lead to infection during surgery if the device is used without proper sterility.
The device's pouch may have a sterile barrier breach, which could allow contamination during surgery. This poses a risk of infection if the device is used without proper sterility.
Surgical teams using Medtronic Affinity NT CVR with Filter during cardiac procedures are most at risk. Patients undergoing extracorporeal circulation procedures may be affected.
The affected product is Medtronic TRILLIUM AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter, 540T model. It was used in cardiac procedures for up to 6 hours.
Verify if your device has the Medtronic TRILLIUM AFFINITY NT CVR with Filter, 540T model used in cardiac procedures.
The recall is for a possible sterile barrier breach in the pouch, which could lead to infection during surgery.
The official notice does not state if the product is safe to use; it is being recalled due to potential risks.
Check for the Medtronic TRILLIUM AFFINITY NT CVR with Filter, 540T model used in cardiac procedures.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0646-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0646-2018 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.
