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MACE

Maquet Cardiopulmonary AG · Model BO-VHK 11000, SOFTLINE, Neonatal, Sterile · UDI-DI 04037691665726

DTN DTP Prescription

510(k) clearances

490

Adverse events (24 deaths)

Recalls

Facilities

Description

Neonatal Venous Hardshell Cardiotomy Reservoir (MACE) neonatal with SOFTLINE Coating, vacuum-tight, Sterile. The Neonatal (VHK 11000) Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. Both reservoirs are of identical design, differing only in the size, to enable the defined performance within flow rates, required for neonatal or pediatric patients. The reservoirs can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Recalls

Date	Firm	Reason
2023-05-18	Maquet Medical Systems USA	1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and c
2021-04-27	Circulatory Technology Inc.	The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the ve
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp
2021-02-04	Medtronic Perfusion Systems	Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory resp

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.