Affinity Fusion recallZ-1026-2023 · Medtronic Perfusion Systems · initiated Dec 12, 2022

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.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number

Z-1026-2023

Status

Open, Classified

Initiated by the company

Dec 12, 2022

Posted by the FDA

Jan 27, 2023

Recalling firm

Medtronic Perfusion Systems

Quantity

4,462 units

Product code

DTZ

FDA submissions

K203111

Distribution

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.

Product description

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Affinity Fusion™ CB841

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports

Product lines

• Affinity FusionMedtronic, Inc. · 10 models · 206 reports · 5 recalls

Other devices under the same FDA submission

5 devices cleared under K203111 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Affinity Fusion® BB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls90 reports
• Affinity Fusion® BB841

  Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
  2 recalls36 reports
• Affinity Fusion™ CB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall4 reports
• Affinity Pixie™ BBP241

  Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
  1 recall2 reports
• Affinity Pixie™ BBP211

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  12 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91343).

• Z-1023-2023 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
• Z-1024-2023 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
• Z-1025-2023 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
• Z-1027-2023 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
• Z-1028-2023 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.