Triever20 Aspiration Guide Catheter a component of FlowTriever… — Class II medical device recall Z-2299-2020
Terminated recall by INARI MEDICAL, reported 2020-06-17, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum durin
| Recall number | Z-2299-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INARI MEDICAL, Irvine, CA, United States |
| Recall initiated | 2020-03-23 |
| Classified | 2020-06-08 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-08-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI |
| Quantity | 318 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00850291007079 |
| Lot numbers | 20010004, 20010005, 20010008 |
Product
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Reason for recall
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
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-2299-2020. 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.