Maquet recalls Heartstring III Proximal Seal System (4.3 MM) due to risk of hemostasis failure during vascular surgery. Affected units include specific serial numbers and model HSK-3043. Consumers should contact Maquet for details.
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 the Heartstring III Proximal Seal System (4.3 MM) because it can fail to seal blood vessels properly during surgery, potentially causing uncontrolled bleeding. This is a serious risk for patients undergoing vascular procedures.
The device can fail to load, deploy into the aorta, or maintain proper blood sealing during surgery. If these failures occur, it could lead to uncontrolled bleeding and serious injury or death.
Patients undergoing vascular surgery who may have received this specific model of Heartstring seal system are at risk. Medical professionals using the device for intravascular anastomosis are most affected.
Check for model number HSK-3043 and serial numbers listed in the recall notice. The device is used in vascular surgery procedures to seal blood vessels.
If you have the recalled Heartstring III Proximal Seal System, stop using it immediately to prevent potential bleeding complications.
The device can fail to load, deploy, or maintain hemostasis during surgery, potentially causing uncontrolled bleeding and serious injury.
Check for model number HSK-3043 and serial numbers listed in the recall notice, which include specific numbers like 3000379223 and 3000488054.
Stop using it immediately and contact Maquet Cardiovascular for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2588-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2588-2025 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.
