Z-2587-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2025
- Initiation Date
- August 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,331 units (16,615 US, 11,716 OUS)
Product Description
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
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.
Distribution Pattern
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.
Code Information
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.