Agency classClass IOur severity:Severe FDA (Devices)·Z-1194-2021·Announced 2021-03-24

Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous 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 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface. The specific product is the Medtronic Custom Pack EVNP Clinical with AP40 1/B, identified by model number M448036B and lot number 220798975. 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 may result in patients developing an acute inflammatory response.

The affected units were distributed worldwide, including in the United States and 23 other countries. The source text does not specify the number of patients affected or report any specific illnesses or injuries. Healthcare providers and patients should check their inventory and usage records for the specific lot number and model number listed above.

The recalled product

Product: Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 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: bacterial-endotoxin
inflammatory-response
Affected units: 10

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