FDA (Devices) recall action 87271

Medtronic Perfusion Systems recalled 10 products on 2021-03-24

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2021-03-24
Critical: 1
Units: 2,548

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

SevereFDA (Devices)··2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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…
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SevereFDA (Devices)··2021-03-24
Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin
Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.
Product
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store…
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SevereFDA (Devices)··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.
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…
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0 states
SevereFDA (Devices)··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.
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…
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0 states
SevereFDA (Devices)··2021-03-24
Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin
Medtronic is recalling 57 units of Affinity Pixie oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and…
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SevereFDA (Devices)··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.
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…
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0 states
SevereFDA (Devices)··2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 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…
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0 states
CriticalFDA (Devices)··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.
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…
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0 states
SevereFDA (Devices)··2021-03-24
Medtronic Infant Tubingset Recalled for Elevated Bacterial Endotoxin Levels
Medtronic is recalling 14 units of infant tubingsets due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 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…
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SevereFDA (Devices)··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.
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…
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