The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1198-2021·Announced 2021-03-24

Medtronic Pediatric Cardiotomy Reservoir Recalled for Bacterial Endotoxin

Medtronic is recalling 4 units of a pediatric cardiotomy reservoir 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 4 units of the Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The specific product involved is the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface, a single-use device designed to collect and store blood during extracorporeal circulation. The affected lot number is 220906731.

The recall was initiated because the devices may contain potentially elevated levels of bacterial endotoxin. Exposure to elevated levels of bacterial endotoxins may cause patients to develop an acute inflammatory response. The source text does not report any specific illnesses or injuries associated with this recall.

The affected units 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. Healthcare providers and patients should contact Medtronic Perfusion Systems for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). 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…
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass
Hazard
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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