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KIDS
SORIN GROUP ITALIA SRL · Model D100 · UDI-DI 08033178112840
1
510(k) clearances
10,612
Adverse events (449 deaths)
107
Recalls
34
Facilities
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.