Cardiopulmonary Bypass Oxygenator Recalled for Loose Temperature Monitoring Adapter
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is FDA Class II equipment with no reported hospitalizations or injuries to date. However, it involves a critical cardiac support device where a loose component could pose significant risk to patients during heart surgery. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model CB811), used during cardiopulmonary bypass procedures.
The Temperature Monitoring Adapter (TMA) on the oxygenator has come loose in multiple reported cases, either during pre-procedure setup or when disassembling the perfusion circuit after use. This represents an upward trend of reported complaints.
The affected units have worldwide distribution, including the United States and numerous countries across Africa, Americas, Asia, Europe, and the Middle East. Serial numbers range from 8111483548 to 8113999999, with specific lot numbers identified in the recall.
Healthcare facilities using this equipment should inspect the Temperature Monitoring Adapter to ensure it is securely attached before each use. Units with loose or detached adapters should be removed from service immediately. Contact Medtronic Perfusion Systems for guidance on repair or replacement of affected units.
The recalled product
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- loose-adapter
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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)
Distribution
Distributed nationwide across the United States.
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