—#197681

Product

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K203111
Affected lot / code info: Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00763000225476 (Lot Numbers: 225313243, 225400271, 225467451, 225467452); GTIN Number: 00763000225483 (Lot Numbers: 13392578, 13394967, 224274665, 224426764, 225332708, 225332709, 225467446, 225467447)

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

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.

Timeline

Recall initiated: 2022-12-12
Posted by FDA: 2023-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197681. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.