Agency classClass IOur severity:Severe FDA (Devices)·Z-1196-2021·Announced 2021-03-24

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.

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

See all 10 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · bacterial endotoxin