Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels
Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric.
Plain-English summary
Medtronic Perfusion Systems is recalling 4 units of the Medtronic Custom Perfusion Pack (Model HY11B40R1, Lot 220911913). The recall is due to potentially elevated levels of bacterial endotoxin in the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use device used to collect and store blood during extracorporeal circulation.
The FDA classifies this as a Class I recall. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. The affected units were distributed worldwide, including the United States, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam.
Healthcare providers should stop using the affected units and contact Medtronic Perfusion Systems for further instructions. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). 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, filte
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 4
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.
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