Maquet Cardiovascular recalled the Heartstring III Proximal Seal System on August 15, 2025, due to three identified failure modes. These failures include issues with the seal's loading, deployment, and hemostasis. The recall affects 168 units distributed worldwide.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular, LLC or your healthcare provider for instructions. Notification method: Letter
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The recalled Heartstring III Proximal Seal System includes model HS-3045 and UDI 00607567700307. Other serial numbers affected are 3000365549, 3000428264, 3000447331, 3000460255, 3000390361, 3000420107, and 3000475915. The device was distributed in various countries, including the US, Canada, and several European nations.
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