Medtronic Heart Valve Division
FDA adverse event reports naming Medtronic Heart Valve Division as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC HEART VALVE DIVISION.
- Total reports
- 1,864
- Deaths
- 48
- Injuries
- 1,809
- Malfunctions
- 7
Reports per year
Source: FDA adverse event reports by year received, 2014–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2008-08-27TerminatedProcess control
Hall Easy-Fit Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.
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.
- 2008-08-27TerminatedProcess control
Hall Easy-Fit Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.
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.
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