Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2025