Maquet Cardiovascular, LLC — Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 15, 2025
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.
What's affected?
- Product
- Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Lot code
- Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.
Additional details
Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 126 units (91 US, 35 OUS).
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