Home › Maquet Cardiopulmonary AG › PLEGIOX Cardioplegia Heat Exchanger
PLEGIOX Cardioplegia Heat Exchanger
Maquet Cardiopulmonary AG · Model BO-CHX 30, SOFTLINE, Sterile · UDI-DI 04037691229591
1
510(k) clearances
10,612
Adverse events (449 deaths)
107
Recalls
34
Facilities
Description
PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
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 | 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 | 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 | 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 |
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Get your free API keyRead the docsData 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.