Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
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 classified this as a Class I recall, which mandates a minimum score of 4 per the rubric. The hazard involves elevated bacterial endotoxin levels that may cause an acute inflammatory response, a significant health risk.
Plain-English summary
Medtronic Perfusion Systems is recalling 70 units of the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface. The specific product is the Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR), model BB10H89R4, lot number 220265395. This single-use device is designed to collect and store blood during extracorporeal circulation.
The recall was initiated because the devices may contain potentially elevated levels of bacterial endotoxin. Exposure to elevated levels of bacterial endotoxins can lead to an acute inflammatory response in patients. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected units were distributed worldwide, including in the United States and 23 other countries such as 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 and facilities should stop using the affected lot and contact Medtronic Perfusion Systems for further instructions on return or replacement.
The recalled product
- Product
- Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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 defoamed
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 70
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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