Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Recall
- Recall Number
- Z-2588-2025
- Event Number
- 97450
- Firm
- Maquet Cardiovascular, LLC
- FEI Number
- 2242352
- Product Code
- DXC
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 15, 2025
- Posted
- September 18, 2025
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
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.
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.
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.
12,471 units (6,565 US, 5,906 OUS)