ClotTriever XL Catheter — Class I medical device recall Z-2587-2024
Ongoing recall by Inari Medical - Oak Canyon, reported 2024-08-28, distributed nationwide. Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circum
| Recall number | Z-2587-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inari Medical - Oak Canyon, Irvine, CA, United States |
| Recall initiated | 2024-07-19 |
| Classified | 2024-08-21 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, NZ |
| Quantity | 2,488 |
| UPC / GTIN / UDI-DI | 00850291007277 |
| Lot numbers | IU-01011 |
| Model numbers | 41-102 |
Product
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Reason for recall
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
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-2587-2024. 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.