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Medtronic Core Valve, LLC

Last updated May 23, 2026

Information

Country: US
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Catalogue (73)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
CoreValve™ Evolut™	MCS-P3-31-AOA-US	FDA UDI	Class III	Unknown
EnVeo™ R	ENVEOR-N-US	FDA UDI	Class III	Active
EnVeo™ R	LS-MDT2-23-US	FDA UDI	Class III	Active
CoreValve™	DCS-C4-18F-US	FDA UDI	Class III	Unknown
EnVeo™ R	ENVEOR-US	FDA UDI	Class III	Active
Evolut™ FX+	EVFXPLUS-29	FDA UDI	Class III	Active
Evolut™ FX	L-EVOLUTFX-2329	FDA UDI	Class III	Active
Evolut™ FX	EVOLUTFX-34	FDA UDI	Class III	Active
CoreValve™ Evolut™ R	EVOLUTR-34-US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-26-AOA-US	FDA UDI	Class III	Unknown
Evolut™ PRO+	D-EVPROP34US	FDA UDI	Class III	Active
CoreValve™ Evolut™ R	EVOLUTR-23-US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P4-23-AOA	FDA UDI	Class III	Unknown
CoreValve™	CLS-3000-18FR	FDA UDI	Class III	Unknown
CoreValve™	CLS-3000-18F-US	FDA UDI	Class III	Unknown
Evolut™ PRO+	EVPROPLUS-26US	FDA UDI	Class III	Active
Evolut™ FX+	EVFXPLUS-34	FDA UDI	Class III	Active
Evolut™ PRO+	EVPROPLUS-29US	FDA UDI	Class III	Active
EnVeo™ R	ENVEOR-US	FDA UDI	Class III	Active
CoreValve™	DCS-C4-18FR-23	FDA UDI	Class III	Unknown
CoreValve™ Evolut™ PRO	EVOLUTPRO-29-US	FDA UDI	Class III	Unknown
Evolut™ FX	D-EVOLUTFX-2329	FDA UDI	Class III	Active
CoreValve™	DCS-C4-18FR	FDA UDI	Class III	Unknown
Evolut™ PRO+	L-EVPROP34US	FDA UDI	Class III	Active
CoreValve™ Evolut™ PRO	EVOLUTPRO-26-US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-31-AOA	FDA UDI	Class III	Unknown
Evolut™ FX	D-EVOLUTFX-34	FDA UDI	Class III	Active
Evolut™ PRO+	L-EVPROP2329US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-31-AOA-US	FDA UDI	Class III	Unknown
Evolut™ FX	L-EVOLUTFX-2329	FDA UDI	Class III	Active
Evolut™ FX	EVOLUTFX-29	FDA UDI	Class III	Active
EnVeo™ R	ENVEOR-N-US	FDA UDI	Class III	Active
Evolut™ FX	D-EVOLUTFX-34	FDA UDI	Class III	Active
CoreValve™ Evolut™ R	EVOLUTR-29-US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-29-AOA-US	FDA UDI	Class III	Unknown
EnVeo™ R	ENVEOR-N-US	FDA UDI	Class III	Active
CoreValve™	DCS-C4-18F-23US	FDA UDI	Class III	Unknown
CoreValve™ Evolut™ R	EVOLUTR-23-US	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-29-AOA	FDA UDI	Class III	Unknown
EnVeo™ R	LS-ENVEOR2629US	FDA UDI	Class III	Active
EnVeo™ R	LS-ENVEOR23US	FDA UDI	Class III	Active
Evolut™ FX+	EVFXPLUS-23	FDA UDI	Class III	Active
CoreValve™ Evolut™ PRO	EVOLUTPRO-23-US	FDA UDI	Class III	Active
CoreValve™	DCS-C4-18F-US	FDA UDI	Class III	Unknown
Evolut™ FX+	EVFXPLUS-26	FDA UDI	Class III	Active
Evolut™ PRO+	EVPROPLUS-34US	FDA UDI	Class III	Active
Evolut™ FX	D-EVOLUTFX-2329	FDA UDI	Class III	Active
CoreValve™ Evolut™	MCS-P3-29-AOA	FDA UDI	Class III	Unknown
Evolut™ FX	EVOLUTFX-26	FDA UDI	Class III	Active
CoreValve™ Evolut™ PRO	EVOLUTPRO-26-US	FDA UDI	Class III	Unknown

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 14, 2020	Z-1450-2020	—	open, classified	Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
Jan 14, 2020	Z-1449-2020	—	open, classified	Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.