Maquet recalls Heartstring III Proximal Seal System for potential bleeding during surgery. Affected units have specific serial numbers and model numbers. Contact for return or replacement.
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 due to risks of bleeding during surgery. This device is used in cardiovascular procedures to seal blood vessels. The recall affects specific serial numbers and model numbers.
The device can fail in three ways: not loading properly, not deploying into the aorta, or failing to stop bleeding after deployment. These failures could lead to uncontrolled bleeding during surgery.
Surgical teams using the Heartstring III Proximal Seal System for cardiovascular procedures are most at risk. Patients undergoing surgery with this device may experience uncontrolled bleeding.
Check for model number HS-3045 and serial numbers listed in the recall notice. The device is used in cardiovascular surgeries to seal blood vessels.
Look for the serial numbers listed in the recall notice: 3000365549, 3000428264, 3000447331, 3000460255, 3000475915, and others.
It is an intravascular anastomosis occluder used in cardiovascular surgery to seal blood vessels.
The affected serial numbers are 3000365549, 3000428264, 3000447331, 3000460255, 3000475915, and others as listed in the recall notice.
The recall notice states that the remedy is null, meaning no specific action is required beyond checking the serial numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2586-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2586-2025 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.
