Class 2 Device Recall Heartstring III Proximal Seal System

• Date Initiated by Firm: August 15, 2025
• Date Posted: September 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2588-2025
• Recall Event ID: 97450
• 510(K)Number: K130382
• Product Classification: Clamp, vascular - Product Code DXC
• Product: Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• Manufacturer 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 Determined 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 recallresponses.qrc@getinge.com. 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DXC