Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Recalled by Maquet Cardiovascular, LLC Due to Three failure modes have been identified: failure of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular, LLC directly.
Affected Products
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Quantity: 126 units (91 US, 35 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular, LLC
Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report