Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach
Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterile barrier breach in a medical device used during surgery, which poses a risk of harm without reported injuries.
Plain-English summary
Medtronic Perfusion Systems is recalling the TRILLIUM AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter, including both uncoated and Trillium coated versions. The recall involves 3,864 units distributed worldwide, including the United States, Australia, Canada, and several other countries.
The recall is being conducted because of a possible sterile barrier breach in the pouch of the device. This device is a single-use medical product designed to collect and store blood during extracorporeal circulation in routine cardiopulmonary procedures.
Healthcare facilities and users should stop using the affected devices and contact Medtronic Perfusion Systems for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,864
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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