Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Reported: September 24, 2025 Initiated: August 15, 2025 #Z-2587-2025
Product Description
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 28,331 units (16,615 US, 11,716 OUS)
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.. Recalled by Maquet Cardiovascular, LLC. Units affected: 28,331 units (16,615 US, 11,716 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2587-2025.
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