Heartstring III Proximal Seal System — Class II medical device recall Z-2588-2025
Ongoing recall by Maquet Cardiovascular, LLC, reported 2025-09-24, distributed nationwide. Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring
| Recall number | Z-2588-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2025-08-15 |
| Classified | 2025-09-18 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IL, IT, JP, KR, LU, MY, NL, NO, NZ, PL, PT, SA, SE, SG, SI, SK, TR |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00607567700321 |
| Serial numbers | 3000378620, 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000408189, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074, 3000438076, 3000438521, 3000442986, 3000444153, 3000444386, 3000451113 and 23 more |
| Model numbers | HSK-3043 |
Product
Heartstring III Proximal Seal System, 4.3 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2588-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.