Home › Inari Medical, Inc. › RevCore Thrombectomy Catheter
RevCore Thrombectomy Catheter
Inari Medical, Inc. · Model 44-101 · UDI-DI 00850291007383
QEW
Prescription
1
510(k) clearances
1,318
Adverse events (128 deaths)
10
Recalls
72
Facilities
Description
RevCore Thrombectomy Catheter (Thrombectomy Catheter)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-08 | Inari Medical - Oak Canyon | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally incr |
| 2024-07-19 | Inari Medical - Oak Canyon | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected |
| 2024-05-01 | Mermaid Medical A/S | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.