Medtronic Perfusion Systems: Medical Device Recall in 2023 - (Recall #: Z-1023-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 12, 2022

Date Posted: February 8, 2023

Recall Number: Z-1023-2023

Event ID: 91343

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.

Status: Ongoing

Product Quantity: 2,937 units

Code Information:

Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)

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.

Voluntary or Mandated:

Voluntary: Firm initiated