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Medtronic Heart Valves Division

Medtronic Heart Valves Division Recalls

All product recalls associated with Medtronic Heart Valves Division.

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Recall Summary

Total Recalls

7

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2021

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–7 of 7 recalls

Medtronic Heart Valves Division: CoreValve Evolut PRO PLUS Delivery Catheter System, REF: ...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPR...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Jun 11, 2021

AL, AK, AZ +45 more

• Medtronic Heart Valves Division

Medtronic Heart Valves Division: Evolut (TM) R System. With the following model numbers: ...

Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

FDAOct 23, 2020Nationwide• Medtronic Heart Valves Division

Medtronic Heart Valves Division: Evolut (TM) PRO System. With the following model numbers...

Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

FDAOct 23, 2020Nationwide• Medtronic Heart Valves Division

Medtronic Cardiovascular Surgery-the Heart Valve Division: Hancock Apical Left Ventricle Connector, Model No. H174Ax...

Medtronic has decided to discontinue production and distribution of this low-volume product.

Class IIModerate

FDAAug 15, 2014IN, MD, TX• Medtronic Cardiovascular Surgery-the Heart Valve Division

Medtronic Heart Valve Division: Hall Easy-Fit Prosthetic Heart Valve - Aortic A7700. Th...

Medtronic has identified an issue with 685 Hall Easy-Fit valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.

FDAMar 25, 2008AR, CA, IL +11 more• Medtronic Heart Valve Division