Heartstring III Proximal Seal System. Intravascular recall
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Why was Heartstring III Proximal Seal System. Intravascular 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.
- Product
- Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 126 units (91 US, 35 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.
- Recall date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)