Maquet recalls Heartstring III Proximal Seal System (3.8 MM) due to risk of hemostasis failure during vascular surgery. Affected units have specific serial numbers and model numbers.
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.
Maquet is recalling its Heartstring III Proximal Seal System (3.8 MM) because it can fail to load, deploy, or provide adequate hemostasis during vascular surgery. This could lead to uncontrolled bleeding if used incorrectly.
The device can fail to load properly, deploy into the aortotomy, or maintain adequate hemostasis after deployment. This risk occurs during vascular surgery procedures where precise control is critical.
Medical professionals using this device during vascular surgery are most at risk. The recall applies to specific serial numbers and model numbers listed in the official notice.
Check for the model number HSK-3038 and serial numbers listed in the official recall notice. The device is used in vascular surgery procedures.
Look for the serial numbers listed in the official recall notice to confirm if your device is affected.
The Heartstring III Proximal Seal System can fail to load, deploy into the aortotomy, or provide adequate hemostasis during vascular surgery, which could lead to uncontrolled bleeding.
Check the serial number against the list provided in the official recall notice to determine if your device is affected.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2587-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2587-2025 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
