Maquet Cardiovascular, LLC 2025-09-24 Health serious FDA
Health · FDA · Recall #FDA-Z-2586-2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Recall
Issued September 24, 2025 · Maquet Cardiovascular, LLC
In September 2025, Maquet Cardiovascular, LLC recalled the Heartstring III Proximal Seal System. Intravascular anastomosis occluder., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
- 1 Stop using Heartstring III Proximal Seal System. Intravascular anastomosis occluder. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Maquet Cardiovascular, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Maquet Cardiovascular, LLC
- Category
- Health
- Recall date
- September 24, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Re
- Recall number
- FDA-Z-2586-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Maquet Cardiovascular, LLC has 7 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.