—#215625

Product

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

FDA product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K130382
Affected lot / code info: Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-08-15
Posted by FDA: 2025-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215625. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.