Open, Classified

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

FDA Recall Z-1023-2023 · Posted 2023-01-27

Recalling FirmMedtronic Perfusion Systems

Recall StatusOpen, Classified

Product CodeDTZ

Date Initiated2022-12-12

Product Quantity2,937 units

Reason for Recall

An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

Firm Action

Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection during the clinical procedure. Consignees were also advised to complete and return the Customer Confirmation Form, and notify personnel or facilities were affected units are located. On about 02/10/2023, Medtronic initiated an expansion and notified customers. Instructions in the customer letter remained the same.

Root Cause

Process change control

Distribution Pattern

Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic · 2021-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.