Agency classClass IOur severity:Critical FDA (Devices)·Z-1195-2021·Announced 2021-03-24

Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels

Medtronic is recalling 4 units of Custom Perfusion Packs 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric.

Plain-English summary

Medtronic Perfusion Systems is recalling 4 units of the Medtronic Custom Perfusion Pack (Model HY11B40R1, Lot 220911913). The recall is due to potentially elevated levels of bacterial endotoxin in the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use device used to collect and store blood during extracorporeal circulation.

The FDA classifies this as a Class I recall. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. The affected units were 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 units and contact Medtronic Perfusion Systems for further instructions. Consumers should not use these devices if they have them in their possession.

The recalled product

Product: Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). 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
Category: Medical Device — Cardiopulmonary Bypass
Hazard: bacterial-endotoxin
inflammatory-response
Affected units: 4

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 →

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Same hazard · bacterial endotoxin