Medtronic Heart Valves Division FDA Recalls

4 recalls on file across devices, 1 of them Class I and 4 still open. Matched by name to MDT.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Medtronic Harmony Delivery Catheter SystemClass IMay 22, 2026Devices containing inner shaft assemblies from specific manu	Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for	Class IDevices	May 22, 2026
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;Class IIJun 11, 2021Due to reports of actuator separation for various delivery c	Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactu	Class IIDevices	Jun 11, 2021
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;Class IIJun 11, 2021Due to reports of actuator separation for various delivery c	Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactu	Class IIDevices	Jun 11, 2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;Class IIJun 11, 2021Due to reports of actuator separation for various delivery c	Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactu	Class IIDevices	Jun 11, 2021