Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin
Medtronic is recalling 57 units of Affinity Pixie oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
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 involves a high-risk medical device with a potential for harm (acute inflammatory response) but does not explicitly report injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 57 units of the Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface. The recall is due to potentially elevated levels of bacterial endotoxin in the devices.
The Affinity Pixie Cardiotomy/Venous Reservoir is a single-use device designed to collect and store blood during extracorporeal circulation. It is used in cardiopulmonary bypass procedures. The primary blood-contacting surfaces are coated with Balance Biosurface to reduce platelet activation and adhesion.
Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. The affected units were distributed worldwide, including in the United States and numerous international locations. Healthcare providers should stop using the recalled devices and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and sto
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 57
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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