Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk
Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of at least 4. The hazard involves potential serious adverse health consequences (acute inflammatory response) from bacterial endotoxins.
Plain-English summary
Medtronic Perfusion Systems has initiated a recall of the Custom Perfusion System (specifically the CUSTOM PACK HY10J00R6 ECC SMALL CAR model). The recall affects three units distributed worldwide, including in the United States and several other countries such as Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, the United Arab Emirates, the United Kingdom, Uzbekistan, and Viet Nam.
The products are being recalled because they may contain an elevated level of bacterial endotoxin. According to the recall notice, patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
This is a Class I recall by the U.S. Food and Drug Administration, indicating a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, an
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 3
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 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 · bacterial endotoxin
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
FDA (Devices) · 2025-04-02
- HighShoulder implant recalled due to excessive bacterial endotoxin
FDA (Devices) · 2024-09-25
- HighCook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels
FDA (Devices) · 2024-05-22
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22