Z-2588-2025Class II

Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder

Name: Z-2588-2025 Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
Creator: Maquet Cardiovascular, LLC
Published: 2025-08-15
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2025-08-15 / Open, Classified

FDA source

Maquet Cardiovascular, LLC began a recall of Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder on 2025-08-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2588-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-15
Posted: 2025-09-18
Recalling firm: Maquet Cardiovascular LLC
Product: Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Product code: DXC Clamp, Vascular
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.
FDA root cause: Under Investigation by firm
Action: Consignees were sent an URGENT MEDICAL DEVICE CORRECTION notification dated August 2025. The notification provides instructions for consignees to carry out in the instance of failure of the Heartstring Seal to load, failure of the Heartsring III Seal to deploy into the aortotomy, and failure of the deployed Heartstring III Seal to provide adequate hemostasis. Consignees are asked to forward the recall notification to individuals within their organization who use the recalled devices and to organizations to which product was further distributed. Consignees are to return the completed response form to [email protected]. Questions about this recall can be directed to Getinge Customer Service at 1-888-880-2874. ****Update 4/17/2026**** On August 15, 2025 URGENT MEDICAL DEVICE CORRECTION lupdate letters were sent to customers providing updated instructions for consignees to carry out in the instance of failure of the Heartstring Seal to load, failure of the Heartsring III Seal to deploy into the aortotomy, and failure of the deployed Heartstring III Seal to provide adequate hemostasis. Consignees are asked to forward the recall notification to individuals within their organization who use the recalled devices and to organizations to which product was further distributed. Consignees are to return the completed response form to [email protected]. Questions about this recall can be directed to Getinge Customer Service at 1-888-880-2874.
Quantity in commerce: 12,471 units (6,565 US, 5,906 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2588-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2586-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18
Z-2587-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18
Z-2588-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18

Product code DXC

K130382Class IIHeartstring III Proximal Seal SystemBoston Scientific Corporation / cleared 2013-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)