Heart Valve, More Than Minimally Manipulated Allograft
FDA adverse event reports and recall history for heart valve, more than minimally manipulated allograft (product code OHA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 110
- Deaths
- 8
- Injuries
- 92
- Malfunctions
- 2
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-08-08Open, ClassifiedUnder Investigation by firm
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- 2024-04-16Open, ClassifiedUnder Investigation by firm
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- TerminatedMaterial/Component Contamination
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- TerminatedUnder Investigation by firm
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
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