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Ellipsys Vascular Access System

AVENU MEDICAL, INC. · Model AMI6005 · UDI-DI 00763000496982

PQK Prescription

510(k) clearances

486

Adverse events (7 deaths)

Recalls

Facilities

Description

The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

Recalls

Date	Firm	Reason
2019-04-12	Bard Peripheral Vascular Inc	The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the mag

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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.