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
- HS-3045
- 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
Heartstring III Proximal Seal System is an intravascular occluder used in aortic surgery to achieve hemostasis at the aortotomy.
Why This Is Dangerous
The device has three identified failure modes: loading failure, deployment failure into the aortotomy, and inadequate hemostasis.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals may need to halt procedures using this device and switch to alternative closure methods, which could affect surgical planning and patient flow.
Practical Guidance
How to identify if yours is affected
- Verify device model HS-3045 and UDI 00607567700307 against inventory.
- If matched, follow the recall instructions from Maquet Cardiovascular and your institution.
Where to find product info
Refer to Maquet Cardiovascular recall communications and the FDA enforcement page Z-2586-2025.
What timeline to expect
Remedies and replacement timelines are determined by the manufacturer and hospital procurement processes; expect several weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact the manufacturer using official channels
- Engage regulatory authorities if necessary
How to prevent similar issues
- Implement recall tracking in hospital inventory systems
- Confirm device model and serial numbers before use in any procedure
- Stay updated with FDA/Regulatory notices for medical devices similar to this category
Documentation advice
Document all recalled units, patient cases affected, and communications with the manufacturer.
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Product Details
Model No. HS-3045; UDI 00607567700307; Serial Nos 3000365549, 3000428264, 3000447331, 3000460255, 3000390361, 3000420107, 3000475915; Quantity: 168 units; Distribution: Worldwide (including US); Sold since: Unknown; Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 168 units recalled worldwide
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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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