Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin
Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response."
Plain-English summary
Medtronic Perfusion Systems is recalling the Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface. The recall is due to potentially elevated levels of bacterial endotoxin found 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 conjunction with the oxygenator to filter and defoam blood. 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 recall involves 2,374 units 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 lots and contact Medtronic for further instructions.
The recalled product
- Product
- Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store…
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 2,374
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 13337110
- 13337675
- 13339043
- 13339133
- 13339290
- 13339452
- 13339527
- 13344325
- 13344487
- 13344594
- 13344819
- 13346564
- 13346733
- 13347774
- 13347907
- 13347974
- 13348151
- 13348285
- 13348909
- 13348974
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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