Agency classClass IOur severity:Severe FDA (Devices)·Z-1192-2021·Announced 2021-03-24

Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.

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 classification is FDA Class I, which per the rubric mandates a score of at least 4. The hazard involves potential serious adverse health consequences (acute inflammatory response) from bacterial endotoxins.

Plain-English summary

Medtronic Perfusion Systems has initiated a recall of the Custom Perfusion System (specifically the CUSTOM PACK HY10J00R6 ECC SMALL CAR model). The recall affects three units distributed worldwide, including in the United States and several other countries such as Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, the United Arab Emirates, the United Kingdom, Uzbekistan, and Viet Nam.

The products are being recalled because they may contain an elevated level of bacterial endotoxin. According to the recall notice, patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

This is a Class I recall by the U.S. Food and Drug Administration, indicating a situation where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

The recalled product

Product: Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). 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…
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiopulmonary bypass oxygenator
Hazard: bacterial-endotoxin
inflammatory-response
Affected units: 3

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