Medtronic recalls AFFINITY NT Cardiotomy/Venous Reservoirs with Filter due to possible sterile barrier breach in the pouch. This could lead to infection during surgery. Affected units include all lots of the 540 model.
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 Reservoirs with Filter for possible sterile barrier breaches in the pouch. This could lead to infections during surgery if the device is used. The recall affects all units of this model.
The pouch in the device may have a sterile barrier breach, which could allow contaminants to enter the blood during surgery. This poses a risk of infection for patients if the device is used without a properly sealed pouch.
Surgical teams using Medtronic AFFINITY NT Cardiotomy/Venous Reservoirs with Filter during heart surgery are most at risk. Patients undergoing cardiopulmonary procedures with this device could be affected.
Check for the Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Filter model 540. All lots of this product are affected by the recall.
Identify if your device is the Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Filter model 540.
The recall is due to possible sterile barrier breaches in the pouch of the device, which could lead to infections during surgery.
The official recall does not provide a fix; affected units must be checked and potentially discarded.
All lots of the Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Filter model 540 are affected by this recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0645-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0645-2018 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.
