Home › Device types › QEW
Peripheral Mechanical Thrombectomy With Aspiration
FDA product code QEW · Class 2 · Cardiovascular
237
Registered devices
1,351
Adverse events
10
Recalls
146
510(k) clearances
Devices with this code
Artix BG — Inari Medical, Inc.Indigo System — PENUMBRA, INC.Indigo System — PENUMBRA, INC.Indigo System — PENUMBRA, INC.SET Aspirex™ S 8F 110cm — Straub Medical AGArtix AX — Inari Medical, Inc.Indigo — PENUMBRA, INC.Aventus Thrombectomy System — Inquis Medical, Inc.Indigo System Lightning Flash — PENUMBRA, INC.ClotTriever Sheath, 13 Fr — Inari Medical, Inc.Recana Introducer Sheath, 16Fr x 30cm — Intervene, Inc.Indigo System — PENUMBRA, INC.Malibu Aspiration Catheter System — Innova Vascular, Inc.Laguna Clot Retriever System — Innova Vascular, Inc.Prodigy™ Catheter — IMPERATIVE CARE, INC.Pounce Venous Thrombectomy System — Surmodics, Inc.Pounce™ Venous Thrombectomy System — Surmodics, Inc.Indigo System — PENUMBRA, INC.Aspirex® S 8F 85cm — Straub Medical AGCleaner Plus — ARGON MEDICAL DEVICES, INC.WOLF Thrombectomy System, 14F — Devoro Medical Inc.SET Aspirex™ S 6F 135cm — Straub Medical AGMalibu Aspiration Catheter System — Innova Vascular, Inc.Laguna Clot Retriever System — Innova Vascular, Inc.
Recent 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 coul |
| 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 ma |
| 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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