FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Recall number
- Z-2587-2025
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Status
- Open, Classified
- Initiated
- 2025-08-15
- Posted
- 2025-09-18
- Terminated
- not on file
- 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 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.
- 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, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.
- Lot, serial or model codes
- Model No. HSK-3038; UDI: 00607567700314¿; Serial No. 3000377764, 3000378278, 3000379222, 3000379987, 3000383569, 3000388598, 3000390377, 3000394076, 3000396875, 3000398149, 3000400694, 3000402932, 3000403566, 3000404026, 3000404996, 3000405699, 3000407693, 3000409172, 3000409619, 3000410091, 3000410583, 3000412000, 3000412963, 3000415599, 3000416141, 3000417121, 3000417711, 3000418572, 3000418772, 3000419866, 3000420311, 3000422320, 3000422757, 3000423694, 3000424888, 3000425725, 3000428927, 3000429846, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436446, 3000440202, 3000441040, 3000441162, 3000442134, 3000443538, 3000443910, 3000444136, 3000446374, 3000447343, 3000448483, 3000449214, 3000449897, 3000450561, 3000451914, 3000452532, 3000453432, 3000453804, 3000455728, 3000456346, 3000457969, 3000458434, 3000459087, 3000459889, 3000460034, 3000461587, 3000464463, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000473350, 3000475032, 3000475033, 3000476158, 3000476611, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000485833, 3000488966, 3000377764, 3000378278, 3000379222, 3000379987, 3000388598, 3000391049, 3000394076, 3000396875, 3000398149, 3000400694, 3000403566, 3000404026, 3000404996, 3000405699, 3000409172, 3000409619, 3000410091, 3000412000, 3000412963, 3000415599, 3000417121, 3000417752, 3000418572, 3000419866, 3000420311, 3000422320, 3000423694, 3000424888, 3000425725, 3000428927, 3000431259, 3000431934, 3000434091, 3000434862, 3000435356, 3000436032, 3000436109, 3000436446, 3000437664, 3000440202, 3000440757, 3000441162, 3000442134, 3000442635, 3000443538, 3000443910, 3000444136, 3000446374, 3000447140, 3000447343, 3000448483, 3000449214, 3000449897, 3000450292, 3000451914, 3000452532, 3000452651, 3000453432, 3000453804, 3000455728, 3000456197, 3000456346, 3000457780, 3000457969, 3000458434, 3000459889, 3000460034, 3000461587, 3000464463, 3000465228, 3000465229, 3000465676, 3000465679, 3000466111, 3000466878, 3000467559, 3000470706, 3000471492, 3000473348, 3000475032, 3000475033, 3000476158, 3000477574, 3000478410, 3000479294, 3000479465, 3000481661, 3000484284, 3000484896, 3000488349, 3000488742, 3000488966.
- 510(k) numbers
- ["K130382"]
- PMA numbers
- not on file
- Product code
- DXC
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28