Heart-Valve, Mechanical
FDA adverse event reports and recall history for heart-valve, mechanical (product code LWQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,020
- Deaths
- 895
- Injuries
- 5,335
- Malfunctions
- 702
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-08Open, ClassifiedUnder Investigation by firm
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- 2004-07-20TerminatedOther
ATS Open Pivot Mechanical Heart Valve
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
- TerminatedEmployee error
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
On-X Valve was mislabeled with the incorrect serial number.
- TerminatedLabeling mix-ups
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
- TerminatedLabeling mix-ups
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
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