Recall Z-2587-2025 ยท DXC Clamp, Vascular
Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
| Date | Sep 18, 2025 (initiated Aug 15, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 f |
| Quantity | 28,331 units (16,615 US, 11,716 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, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130382 | HEARTSTRING III PROXIMAL SEAL SYSTEM Boston Scientific Corporation, Jun 5, 2013 |