Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brand
- Maquet Cardiovascular
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- HSK-3038
- Sold at
- Unknown
- 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 used in vascular surgery to control bleeding during an aortotomy. The 3.8 mm occluder assists in achieving hemostasis during procedures.
Why This Is Dangerous
Three identified failure modes could prevent loading, prevent deployment, or prevent adequate hemostasis, potentially causing bleeding complications.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must halt use and coordinate with the manufacturer on remediation; patient safety could be impacted if a suitable replacement is not readily available.
Practical Guidance
How to identify if yours is affected
- Verify device is Heartstring III Proximal Seal System
- Check Model No. HSK-3038 and UDI 00607567700314
- Compare device serial numbers against the provided list of affected Serial Nos.
Where to find product info
Device labels and packaging, hospital inventory records, recall notices on the FDA site.
What timeline to expect
Remedy timelines are not specified; hospitals typically coordinate replacements through procurement channels.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Consult Maquet Cardiovascular recall resources via FDA enforcement page for guidance
How to prevent similar issues
- Establish recall checks in procurement and inventory systems
- Verify device UDI and model numbers before implantation
- Maintain direct line to manufacturer recall teams for urgent remediation
Documentation advice
Keep the recall notice, device labels, serial numbers, and all communications with the manufacturer and hospital leadership.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,867 units recalled worldwide
- Model No. HSK-3038
- Worldwide distribution to hospitals including US nationwide and dozens of countries
- Recall date 2025-08-15; Report date 2025-09-24; Status ACTIVE
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