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hilite

Medos Medizintechnik Aktiengesellschaft · Model hilite 7000 hollow fiber oxygenator, model 0061 · UDI-DI 04250358151602

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510(k) clearances

10,703

Adverse events (453 deaths)

107

Recalls

Facilities

Description

The Medos hilite 7000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute.

Recalls

Date	Firm	Reason
2025-09-12	Medtronic Perfusion Systems	Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
2024-01-16	Maquet Medical Systems USA	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis
2024-01-16	Maquet Medical Systems USA	The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis
2023-05-18	Maquet Medical Systems USA	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may resu
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
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
2023-05-18	Maquet Medical Systems USA	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may resu
2023-05-18	Maquet Medical Systems USA	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may resu
2023-05-18	Maquet Medical Systems USA	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may resu
2023-05-18	Maquet Medical Systems USA	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may resu

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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.