Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir 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) due to bacterial endotoxin, but the source text does not report any confirmed illnesses or injuries, 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 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface. The specific product is the Medtronic Custom Pack EVNP Clinical with AP40 1/B, identified by model number M448036B and lot number 220798975. 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 may result in patients developing an acute inflammatory response.
The affected units were distributed worldwide, including in the United States and 23 other countries. The source text does not specify the number of patients affected or report any specific illnesses or injuries. Healthcare providers and patients should check their inventory and usage records for the specific lot number and model number listed above.
The recalled product
- Product
- Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). 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,
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 10
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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