Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall for a component of a device used in critical cardiopulmonary bypass procedures. The detached Temperature Monitoring Adapter is a real failure with an upward trend of complaints, but no injuries or illnesses are reported in the source. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High rating.
Plain-English summary
Medtronic Perfusion Systems is recalling 2,937 units of the Affinity Fusion Oxygenator (Model BB811), a medical device used in cardiopulmonary bypass surgery. The recall affects units distributed worldwide.
The company has received an increasing number of reports that the Temperature Monitoring Adapter (TMA) attached to the oxygenator has come loose from the device. This loosening can occur either during pre-procedure setup of the perfusion circuit or during post-procedure disassembly. A loose adapter could affect the temperature monitoring function during cardiopulmonary bypass procedures.
Affected lot and serial number ranges have been identified by the manufacturer. Healthcare facilities using this device should determine whether they have affected units by comparing their device serial numbers and lot numbers against the recall information and contact Medtronic with questions or if they are affected.
The recalled product
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 2,937
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · component detachment
See all →- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment
FDA (Devices) · 2026-09-30
- ModerateGalt Medical Recalls Boston Scientific Transcarotid Access Kits
FDA (Devices) · 2026-08-19
Similar recalls
- ModerateMedtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect
FDA (Devices) · 2016-12-28
- HighMedtronic Recalls Affinity Fusion Oxygenators Due to Damaged Heat Exchangers
FDA (Devices) · 2014-12-17
- HighOxygenators recalled after a unit failed carbon dioxide transfer requirements
FDA (Devices) · 2025-11-19
- HighMedtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues
FDA (Devices) · 2018-03-14
- HighMedtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging
FDA (Devices) · 2024-05-22
- SevereMedtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin
FDA (Devices) · 2021-03-24