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20G 8CM Stiletto Extended Dwell Catheter

Avia Vascular, LLC · Model PIP200000 · UDI-DI 00850042365052

PND Prescription

510(k) clearances

983

Adverse events (2 deaths)

Recalls

Facilities

Description

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The catheter, hub, and insertion components are integrated into a single housing to enhance ease of use.

Recalls

Date	Firm	Reason
2026-05-21	Bard Access Systems, Inc.	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21	Bard Access Systems, Inc.	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21	Bard Access Systems, Inc.	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2022-09-14	ARROW INTERNATIONAL Inc.	Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related pr
2020-09-14	Becton Dickinson & Company	Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-09-14	Becton Dickinson & Company	Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-03-17	Becton Dickinson & Company	Iincorrectly packaged without the required lidocaine as labeled
2019-09-24	Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.	Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
2019-04-23	Arrow International Inc	Lidstock states the incorrect expiration date for the product

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Data 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.