Maquet Cardiovascular recalled 168 Heartstring III Proximal Seal System intravascular occluders worldwide, including the United States. Three failure modes have been identified: loading the Heartstring Seal, deploying it into the aortotomy, and achieving adequate hemostasis. Healthcare facilities should stop using the device and follow the manufacturer’s recall 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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Heartstring III Proximal Seal System is an intravascular occluder used in aortic surgery to achieve hemostasis at the aortotomy.
The device has three identified failure modes: loading failure, deployment failure into the aortotomy, and inadequate hemostasis.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals may need to halt procedures using this device and switch to alternative closure methods, which could affect surgical planning and patient flow.
Refer to Maquet Cardiovascular recall communications and the FDA enforcement page Z-2586-2025.
Remedies and replacement timelines are determined by the manufacturer and hospital procurement processes; expect several weeks to months.
Document all recalled units, patient cases affected, and communications with the manufacturer.
Model No. HS-3045; UDI 00607567700307; Serial Nos 3000365549, 3000428264, 3000447331, 3000460255, 3000390361, 3000420107, 3000475915; Quantity: 168 units; Distribution: Worldwide (including US); Sold since: Unknown; Price: Unknown.
No injuries or incidents have been reported.
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Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to three identified failure modes. The device may fail to load, deploy, or provide adequate hemostasis during use. Healthcare providers must stop using the device immediately and contact the manufacturer for guidance.
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