Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer 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 used in vascular surgery to control bleeding during an aortotomy. The 3.8 mm occluder assists in achieving hemostasis during procedures.
Three identified failure modes could prevent loading, prevent deployment, or prevent adequate hemostasis, potentially causing bleeding complications.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals must halt use and coordinate with the manufacturer on remediation; patient safety could be impacted if a suitable replacement is not readily available.
Device labels and packaging, hospital inventory records, recall notices on the FDA site.
Remedy timelines are not specified; hospitals typically coordinate replacements through procurement channels.
Keep the recall notice, device labels, serial numbers, and all communications with the manufacturer and hospital leadership.
Model No. HSK-3038. UDI: 00607567700314. Serial Nos: 3000377764, 3000378278, 3000379222, 3000379987, 3000383569, 3000388598, 3000390377, 3000394076, 3000396875, 3000398149, 3000400694, 3000402932, 3000403566, 3000404026, 3000404996, 3000405699, 3000407693, 3000409172. Quantity: 32,867 units. Distribution: Worldwide to hospitals including US nationwide and numerous countries. Recall date: 2025-08-15. Report date: 2025-09-24. Status: ACTIVE. Hazard Level: HIGH. Brand: Maquet Cardiovascular. Categories: Health & Personal Care; Medical Devices. Sold to: Hospitals worldwide.
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.
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.
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