Recall Z-2588-2025
Maquet Cardiovascular, LLC · initiated August 15, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Codes / lots: 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.
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 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.
Details
- Recall number
- Z-2588-2025
- Initiated
- August 15, 2025
- Posted by FDA
- September 18, 2025
- Product code
- DXC – Clamp, Vascular
- Quantity
- 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…
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2586-2025 Class II | Heartstring III Proximal Seal System. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the… | 08/15/2025Open, Classified |
| Z-2587-2025 Class II | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the… | 08/15/2025Open, Classified |