Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to critical failure modes. The recall affects devices distributed globally since August 15, 2025. Users must stop using the device immediately and follow manufacturer instructions.
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 Heartstring III Proximal Seal System, Model No. HSK-3043, has 16,512 units recalled. It was distributed worldwide, including the US and multiple countries, since August 15, 2025.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure to deploy into the aortotomy, and failure to provide adequate hemostasis. These issues pose a significant risk during medical procedures.
The recall does not specify the number of reported incidents or injuries associated with this device. However, the identified failure modes suggest a high potential for serious complications.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by Maquet Cardiovascular, LLC. Contact your healthcare provider for further guidance.
For more information, contact Maquet Cardiovascular, LLC or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2588-2025.
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