Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brand
- Maquet Cardiovascular
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Maquet Cardiovascular
- Product type
- Intravascular Anastomosis Occluder
- Model numbers
- Model No. HSK-3043, UDI: 00607567700321, Serial No. 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404541 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 15, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
The Heartstring III Proximal Seal System is used in surgeries involving intravascular anastomosis to provide occlusion. It is designed to help facilitate blood flow management during surgical procedures under specific conditions.
Why This Is Dangerous
The device may fail to load or deploy properly, compromising hemostasis. This could lead to uncontrolled bleeding or other serious complications during surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device to avoid serious surgical complications. This recall significantly impacts surgical procedures and patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number and serial numbers against the recall announcement.
- Identify where the device is stored and ensure it is no longer accessible for use.
- Contact your healthcare provider to confirm if your specific device is affected.
Where to find product info
Model and serial numbers can typically be found on the device packaging or printed directly on the device body.
What timeline to expect
Expect a few weeks for the processing of returns and refunds.
If the manufacturer is unresponsive
- Follow up via email or phone with the manufacturer.
- Contact your healthcare provider for assistance.
How to prevent similar issues
- Look for devices that comply with current safety standards from recognized agencies.
- Consult healthcare professionals regarding the latest and safest devices for surgical procedures.
Documentation advice
Keep records of communication regarding the recall, including emails, letters, and any return shipping receipts.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model No. HSK-3043
- Multiple serial numbers affected
- Distribution includes US and 26 other countries
- Follow the manufacturer's recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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