FDA-Device2025-09-24Class II
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
Hazard
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.
Sold states
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.
Affected count
126 units (91 US, 35 OUS)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2586-2025Don't want to check this manually?
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