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ENSEMBLE™
MEDTRONIC, INC. · Model NU1020 · UDI-DI 00643169415744
NPV
Prescription
0
510(k) clearances
2,280
Adverse events (77 deaths)
2
Recalls
14
Facilities
Description
DELIV SYS NU1020 ENSEMBLE HDE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Medtronic Heart Valves Division | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedur |
| 2022-03-02 | Medtronic Inc | There is potential for the capsule bond to break during the procedure. |
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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.