NeVasc .070 Aspiration Catheter, 132 cm
Vesalio · Model VC-070-132 · UDI-DI 00851279008989
Description
The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set NeVasc Aspiration Catheter: The NeVasc Aspiration Catheter (also referred to as NeVasc Catheter) is a single lumen, reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed to reduce friction during use. The distal end of the catheter shaft is radiopaque for angiographic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration. Complete dimensions of the catheter are included on the device label. The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter. The NeVasc Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only. Aspiration Tubing Set: As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is provided with a flow switch and is intended to connect the NeVasc Catheter to a compatible aspiration pump. The Aspiration Tubing Set is intended for single use and is provided in a separate package.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-03 | Penumbra, Inc. | Due to manufacturing issues, reperfusion catheters may fractures |
| 2025-02-26 | Qapel Medical Inc. | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. |
| 2025-01-02 | Scientia Vascular, Inc. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. |
| 2024-08-05 | MICROVENTION INC. | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2021-08-13 | IMPERATIVE CARE INC | There is a potential for distal end of catheters to fracture and become detached. |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
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