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XTRA
SORIN GROUP ITALIA SRL · Model PROCEDURE SET BX/175 · UDI-DI 08033178114103
1
510(k) clearances
490
Adverse events (24 deaths)
47
Recalls
32
Facilities
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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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.