Agency classClass IOur severity:Severe FDA (Devices)·Z-1191-2021·Announced 2021-03-24

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.

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 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…
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiopulmonary Bypass
Hazard: bacterial-endotoxin
inflammatory-response
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.

See all 10 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · bacterial endotoxin