NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 180 cm wire System
Vesalio · Model VP-4546-F3RR · UDI-DI 00851279008477
Description
The pVasc Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the vasculature to restore blood flow in vessels blocked by an embolus. The expandable tip is a tubular mesh structure laser cut from Nitinol with radiopaque markers in the middle of the device and distal tip. In its expanded shape, the device creates a highly flexible, hybrid closed cell structure. The pusher assembly is composed of an introducer and delivery pusher and is used to deliver the device to the treatment site. The introducer consists of a polymer tube, which protects the device and distal segment of the delivery pusher from damage and creates an uninterrupted passage for the device to be transferred through the microcatheter. The delivery pusher varies in flexibility from the proximal to distal end with the distal section of the delivery is the most flexible and has a radiopaque marker. The pusher controls the deployment of the pVasc Device and facilitates advancement and removal of the device through a microcatheter. It is used to track the device to the intended delivery site.
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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