The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1199-2021·Announced 2021-03-24

Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can 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 has initiated a recall of the Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The affected product is the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use device designed to collect and store blood during extracorporeal circulation. Specifically, 7 units are involved in this recall.

The recall is necessary because these devices may contain potentially elevated levels of bacterial endotoxins. According to the notice, patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

The affected units have the model number BB7W03R8, GTIN 00643169990562, and lot number 220911945. These products were distributed worldwide, including in the United States, 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.

No further action steps are detailed in the provided source text regarding what consumers or healthcare providers should do at this time.

The recalled product

Product
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). 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 oxygenator
Hazard
Affected units
7

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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