Syntel Silicone Thrombectomy Catheter — Class II medical device recall Z-1824-2024
Ongoing recall by LeMaitre Vascular, Inc., reported 2024-05-22, distributed nationwide. The guide tip can become damaged and result in the tip detaching.
| Recall number | Z-1824-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2024-04-17 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES |
| Quantity | 5,604 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840663109807, 00840663109814, 00840663109821, 00840663109838, 00840663109845 |
| Lot numbers | SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054 and 15 more |
| Model numbers | A4545, A4548, A4554, A4558, A4568 |
Product
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Reason for recall
The guide tip can become damaged and result in the tip detaching.
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-1824-2024. 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.