Home › Device types › DTZ
Oxygenator, Cardiopulmonary Bypass
FDA product code DTZ · Class 2 · Cardiovascular
1,659
Registered devices
10,612
Adverse events
107
Recalls
254
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Intersept® — MEDTRONIC, INC.NA — MEDTRONIC, INC.CAPIOX®FX — TERUMO CORPORATIONNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.A.M.G. PMP Sterile — EUROSETS SRLNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.
Recent 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 |
| 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 |
| 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, |
| 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-ste |
| 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, |
| 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, |
| 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, |
| 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-ste |
| 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-ste |
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