Z-1026-2023Class II

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

Name: Z-1026-2023 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841...
Creator: Medtronic Perfusion Systems
Published: 2022-12-12
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2022-12-12 / Open, Classified

FDA source

Medtronic Perfusion Systems began a recall of Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass on 2022-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1026-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-12
Posted: 2023-01-27
Recalling firm: Medtronic Perfusion Systems
Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
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.
FDA root cause: Process change control
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.
Quantity in commerce: 4,462 units
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 codes and lots: Model CB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00763000225452 (Lot Numbers: 13394614, 13395228, 223819363, 223952969, 224315522, 224448403, 224772847, 224772848, 224772849); GTIN Number: 00763000225469 (Lot Numbers: 13392615, 13394868, 223476442, 223755429, 223796291, 223834097, 223834098, 224174020, 224188890, 224365018, 224419842, 224816179, 225222080, 225273494, 225273495, 225331432, 225332504, 225332505, 225332506, 225332508, 225661147)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1026-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1023-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1024-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1025-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1026-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1027-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1028-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27

Product code DTZ

K203111Class IIAffinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic / cleared 2021-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)