Unrated Medical device recall · FDA · Published August 15, 2025

Maquet Heartstring III Proximal Seal System Recall: Risk of Bleeding During Surgery

Maquet recalls Heartstring III Proximal Seal System for potential bleeding during surgery. Affected units have specific serial numbers and model numbers. Contact for return or replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2586-2025Medical device Maquet ›

Recall notice

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.

Take action

Contact the company

Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling its Heartstring III Proximal Seal System due to risks of bleeding during surgery. This device is used in cardiovascular procedures to seal blood vessels. The recall affects specific serial numbers and model numbers. Read more at govinfonow.com/recall/51602-maquet-heartstring-iii-proximal-seal-system-recall-risk-of-bleeding.

Source Summary by GovInfoNow · govinfonow.com/recall/51602-maquet-heartstring-iii-proximal-seal-system-recall-risk-of-bleeding · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2586-2025

Cite this page

“Maquet Heartstring III Proximal Seal System Recall: Risk of Bleeding During Surgery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51602-maquet-heartstring-iii-proximal-seal-system-recall-risk-of-bleeding. Based on FDA recall #Z-2586-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2586-2025%22&limit=1).

The FDA announced on August 15, 2025, that Maquet Cardiovascular, LLC is recalling the Heartstring III Proximal Seal System due to failure modes that may prevent adequate hemostasis. The agency issued recall number Z-2586-2025 for the Class II device.

How to tell if you have it

Brand: Maquet
Product: Heartstring III Proximal Seal System
Model No.: HS-3045
UDI: 00607567700307
Serial Nos.: 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915

The hazard

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since January 24, 2019. Other recent recalls include a June 2, 2026 issue with Maquet Vasoview Hemopro 2 devices involving out-of-specification sterilization doses and a March 20, 2025 recall for the Maquet VASOVIEW HEMOPRO 2 Endoscopic System due to ceramic C-Ring breakage risk. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recall (June 24, 2026) and Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026).

How to tell if you have this one

Check for model number HS-3045 and serial numbers listed in the recall notice. The device is used in cardiovascular surgeries to seal blood vessels.

Brand
Maquet
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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 number	Product, codes & lots	Quantity
Z-2586-2025	Heartstring III Proximal Seal System. Intravascular anastomosis occluder.; Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.	126 units (91 US, 35 OUS)
Z-2587-2025	Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.; Model No. HSK-3038; UDI: 00607567700314¿; Serial No. 3000377764, 3000378278, 3000379222, 3000379987, 3000383569, 3000388598, 3000390377, 3000394076, 3000396875, 3000398149, 3000400694, 3000402932, 3000403566, 3000404026, 3000404996, 3000405699, 3000407693, 3000409172, 3000409619, 3000410091, 3000410583, 3000412000, 3000412963, 3000415599, 3000416141, 3000417121, 3000417711, 3000418572, 3000418772, 3000419866, 3000420311, 3000422320, 3000422757, 3000423694, 3000424888, 3000425725, 3000428927, 3000429846, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436446, 3000440202, 3000441040, 3000441162, 3000442134, 3000443538, 3000443910, 3000444136, 3000446374, 3000447343, 3000448483, 3000449214, 3000449897, 3000450561, 3000451914, 3000452532, 3000453432, 3000453804, 3000455728, 3000456346, 3000457969, 3000458434, 3000459087, 3000459889, 3000460034, 3000461587, 3000464463, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000473350, 3000475032, 3000475033, 3000476158, 3000476611, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000485833, 3000488966, 3000377764, 3000378278, 3000379222, 3000379987, 3000388598, 3000391049, 3000394076, 3000396875, 3000398149, 3000400694, 3000403566, 3000404026, 3000404996, 3000405699, 3000409172, 3000409619, 3000410091, 3000412000, 3000412963, 3000415599, 3000417121, 3000417752, 3000418572, 3000419866, 3000420311, 3000422320, 3000423694, 3000424888, 3000425725, 3000428927, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436109, 3000436446, 3000437664, 3000440202, 3000440757, 3000441162, 3000442134, 3000442635, 3000443538, 3000443910, 3000444136, 3000446374, 3000447140, 3000447343, 3000448483, 3000449214, 3000449897, 3000450292, 3000451914, 3000452532, 3000452651, 3000453432, 3000453804, 3000455728, 3000456197, 3000456346, 3000457780, 3000457969, 3000458434, 3000459889, 3000460034, 3000461587, 3000464463, 3000465228, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000475032, 3000475033, 3000476158, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000484896, 3000488349, 3000488742, 3000488966.	28,331 units (16,615 US, 11,716 OUS)
Z-2588-2025	Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.; Model No. HSK-3043; UDI: 00607567700321; Serial No. 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000408189, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074, 3000438521, 3000442986, 3000444153, 3000444386, 3000451113, 3000451189, 3000454605, 3000457540, 3000459949, 3000459992, 3000465374, 3000466176, 3000466177, 3000471825, 3000473063, 3000473064, 3000474240, 3000474241, 3000475497, 3000478491, 3000478495, 3000482450, 3000485137, 3000488054, , 3000378620, 3000379223, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074, 3000438076, 3000442986, 3000444153, 3000444386, 3000451113, 3000451189, 3000454605, 3000459949, 3000459992, 3000465374, 3000465479, 3000466177, 3000468296, 3000471825, 3000473064, 3000474240, 3000474241, 3000475497, 3000478491, 3000478495, 3000479466, 3000484006, 3000485137, 3000488054.	12,471 units (6,565 US, 5,906 OUS)

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial numbers listed in the recall notice: 3000365549, 3000428264, 3000447331, 3000460255, 3000475915, and others.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Aug 15, 2025Firm started the recall
Sep 18, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a remedy for this recall?

The recall notice states that the remedy is null, meaning no specific action is required beyond checking the serial numbers.

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Link to this recall

<a href="https://govinfonow.com/recall/51602-maquet-heartstring-iii-proximal-seal-system-recall-risk-of-bleeding">Maquet Heartstring III Proximal Seal System Recall: Risk of Bleeding During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2586-2025 (August 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2586-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.