Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
FDA device recall Z-2587-2025 · posted 2025-09-18 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- 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.
- Action taken
- 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. ****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 recallresponses.qrc@getinge.com. Questions about this recall can be directed to Getinge Customer Service at 1-888-880-2874.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DXC
- Quantity affected
- 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
- Date initiated
- 2025-08-15
- Date posted
- 2025-09-18
- Location
- Wayne, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTRING III PROXIMAL SEAL SYSTEM (K130382) | Boston Scientific Corporation | 2013-06-05 |