Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk
Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can cause acute inflammatory responses in patients.
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 I, which mandates a severity score of at least 4. However, the rubric specifies that if the source text explicitly states no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. The source only mentions the potential for an acute inflammatory response without reporting actual injuries or illnesses.
Plain-English summary
Medtronic Perfusion Systems has initiated a recall of the Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The affected product is the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use device designed to collect and store blood during extracorporeal circulation. Specifically, 7 units are involved in this recall.
The recall is necessary because these devices may contain potentially elevated levels of bacterial endotoxins. According to the notice, patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
The affected units have the model number BB7W03R8, GTIN 00643169990562, and lot number 220911945. These products were distributed worldwide, including in the United States, 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.
No further action steps are detailed in the provided source text regarding what consumers or healthcare providers should do at this time.
The recalled product
- Product
- Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). 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, and defo
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 7
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