Home › Jenavalve Technology, Inc. › Trilogy Transcatheter Heart Valve
Trilogy Transcatheter Heart Valve
Jenavalve Technology, Inc. · Model TRILOGY-THV-M · UDI-DI 00850000898110
NPT
Prescription
0
510(k) clearances
79,967
Adverse events (8,069 deaths)
36
Recalls
25
Facilities
Description
Pericardial THV Size 25MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 2026-07-31 | Jenavalve Technology Inc. | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. |
| 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. |
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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.