Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Summary
The FDA issued a Class II for Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardioto by Medtronic Perfusion Systems. Reason: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements..
Details
Source
Device Recall
External ID
Z-0487-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Lot/Code Info: Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Quantity Affected: 26 units
Reason for Recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Distribution
US States: AZ, CA, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-12
Company
Brooklyn Park, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Perfusion Systems have FDA actions?
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0487-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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