FDA Device recall Z-2588-2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder by Maquet Cardiovascular, citing 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 Hearts….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2588-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-15 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
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.
Identifiers
| code_info | Model No. HSK-3043; UDI: 00607567700321; Serial No. 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2588-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.