Reported Sep 24, 2025 · Ongoing
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
- Lot codes and dates
- Model No. HSK-3043
- UDI
84 of 84 codes
00607567700321Serial No. 30003792233000382433300038592930003914053000399719300040454130004064693000408189300041181630004142533000414613300041521230004197653000421682300042295730004276453000428019300042907430004385213000442986300044415330004443863000451113300045118930004546053000457540300045994930004599923000465374300046617630004661773000471825300047306330004730643000474240300047424130004754973000478491300047849530004824503000485137300048805430003786203000379223300038592930003914053000399719300040454130004064693000411816300041425330004146133000415212300041976530004216823000422957300042764530004280193000429074
- Amount recalled
- 12,471 units (6,565 US, 5,906 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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