Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
FDA Recall #Z-2588-2025 — Class II — August 15, 2025
Product Description
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Reason for Recall
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.
Recalling Firm
Maquet Cardiovascular, LLC — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12,471 units (6,565 US, 5,906 OUS)
Distribution
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.
Code Information
Model No. HSK-3043; UDI: 00607567700321; Serial No. 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000408189, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074, 3000438521, 3000442986, 3000444153, 3000444386, 3000451113, 3000451189, 3000454605, 3000457540, 3000459949, 3000459992, 3000465374, 3000466176, 3000466177, 3000471825, 3000473063, 3000473064, 3000474240, 3000474241, 3000475497, 3000478491, 3000478495, 3000482450, 3000485137, 3000488054, , 3000378620, 3000379223, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074, 3000438076, 3000442986, 3000444153, 3000444386, 3000451113, 3000451189, 3000454605, 3000459949, 3000459992, 3000465374, 3000465479, 3000466177, 3000468296, 3000471825, 3000473064, 3000474240, 3000474241, 3000475497, 3000478491, 3000478495, 3000479466, 3000484006, 3000485137, 3000488054.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated