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Medtronic Heart Valves Division Recalls
7 recalls on record · December 16, 2020 to July 8, 2026 · Medical Devices
Recalls by year
20
21
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026Medical DevicesFDA
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Hazard: Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
July 14, 2021Medical DevicesFDA
Medtronic Heart Valves Division recalls CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Hazard: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
July 14, 2021Medical DevicesFDA
Medtronic Heart Valves Division recalls CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Hazard: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
July 14, 2021Medical DevicesFDA
Medtronic Heart Valves Division recalls CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Hazard: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
December 16, 2020Medical DevicesFDA
Medtronic Heart Valves Division recalls Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM J
Hazard: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
December 16, 2020Medical DevicesFDA
Medtronic Heart Valves Division recalls Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 2
Hazard: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
December 16, 2020Medical DevicesFDA
Medtronic Heart Valves Division recalls Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS
Hazard: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).