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Ellipsys Power Controller

AVENU MEDICAL, INC. · Model AMI1001 · UDI-DI 00763000478193

PQK Prescription

510(k) clearances

486

Adverse events (7 deaths)

Recalls

Facilities

Description

The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.

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.