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LOTUS Edge™ Valve System
BOSTON SCIENTIFIC CORPORATION · Model H749LVSUS230 · UDI-DI 08714729960904
NPT
Prescription
0
510(k) clearances
79,061
Adverse events (8,008 deaths)
33
Recalls
25
Facilities
Description
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura |
| 2024-10-17 | Abbott Medical | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2021-06-11 | Medtronic Heart Valves Division | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. |
| 2020-11-17 | Boston Scientific Corporation | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| 2020-11-17 | Boston Scientific Corporation | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
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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.