Medtronic Recalls Affinity Fusion Oxygenators Due to Damaged Heat Exchangers
Medtronic Perfusion Systems is recalling 168 Affinity Fusion Oxygenators with Carmeda Bioactive Surface due to damaged heat exchangers.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect (damaged heat exchangers) in a critical medical device used for gas exchange, posing a risk of harm without reported fatalities.
Plain-English summary
Medtronic Perfusion Systems has initiated an urgent medical device recall for Affinity Fusion Oxygenation Systems with Carmeda Bioactive Surface. The recall was initially issued for 66 distributed devices and has been updated to include 168 additional devices, affecting a total of 234 units. The affected product is limited to model CB841, which may be sold standalone or incorporated in Total Systems TS1614R1 and TS1595R7.
The recall is due to damaged heat exchangers in the devices. The Affinity Fusion Oxygenator is a single-use, microporous, hollow-fiber, gas-exchange device with an integrated heat exchanger and arterial filter. It is designed to reduce platelet activation and adhesion while preserving platelet function.
The affected devices were distributed in the United States to California and Florida, as well as internationally to the Czech Republic and Switzerland. Specific lot numbers and serial numbers are listed in the official recall documentation. Healthcare providers and patients should contact Medtronic Perfusion Systems for further instructions on how to proceed with the recall.
The recalled product
- Product
- The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blo
- Manufacturer
- Medtronic Perfusion Systems
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 (2)
- 13 (serial # 8110141520)
- 13023057 (Serial # 8110141435 and 8110141539).
Distribution
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
- 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
- HighArterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass
FDA (Devices) · 2026-08-05
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25