Medtronic Perfusion Systems: Medical Device Recall in 2018 - (Recall #: Z-0646-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

Product Classification:

Class II

Date Initiated: January 16, 2018

Date Posted: February 28, 2018

Recall Number: Z-0646-2018

Event ID: 79058

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3864 units

Code Information:

All lots

Distribution Pattern:

Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated