UnratedMedical device recall · FDA · Published January 16, 2018
Medtronic AFFINITY NT CVR with Filter Recall: Possible Sterile Barrier Breach
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.
Take action
Contact the company
📍Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088
“Medtronic AFFINITY NT CVR with Filter Recall: Possible Sterile Barrier Breach.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72132-medtronic-affinity-nt-cvr-with-filter-recall-possible-sterile-barrier. Based on FDA recall #Z-0645-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0645-2018%22&limit=1).
The FDA announced on Jan. 16, 2018, that Medtronic Perfusion Systems is recalling its AFFINITY NT Cardiotomy/Venous Reservoir products due to a possible sterile barrier breach in the pouch. The agency issued recall number Z-0645-2018 for the Class II voluntary recall affecting worldwide distribution.
How to tell if you have it
Brand: Medtronic
Product: AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter, 540
Variants: Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated
Units affected: 8644
The hazard
The recall addresses a possible sterile barrier breach in the pouch of the recalled devices. The AFFINITY NT Cardiotomy/Venous Reservoir is a single-use device designed to collect and store blood during extracorporeal circulation procedures.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Recent brand-specific recalls include the June 24, 2026, EOPA Arterial Cannula recall for pinhole leaks and the May 25, 2026, Pediatric Cannula recall for loose blood material risk. Other recent recalls of similar products include the April 10, 2026, Stryker Medtronic Marinr Steerable Catheter recall for incomplete sterile seals and the June 12, 2026, Medline Convenience Kits recall for risk of sterile packaging breach.
How to tell if you have this one
Check for the Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Filter model 540. All lots of this product are affected by the recall.
Brand
Medtronic
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-0645-2018
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) 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(R) 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.; All lots
8644 units
Z-0646-2018
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.; All lots
3864 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your device is the Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Filter model 540.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0645-2018 (January 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0645-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.