Ellipsys Vascular Access System AMI6005 (REF AMI6005 CE)Recalls & reported problems
Avenu Medical, Inc. · 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. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000496982), received between Dec 5, 2023 and Dec 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Difficult to Remove; Difficult to Remove
A PHYSICIAN WAS ATTEMPTING TO USE AN ELLIPSYS CATHETER. THE IFU WAS FOLLOWED. IT WAS REPORTED THE PHYSICIAN DID NOT ACTIVATE THE DEVICE. INITIAL ACCESS (THROUGH PERFORATOR INTO RADIAL ARTERY) WAS PERFORMED. PLACEMENT OF 'GAP' IN DEVICE WAS ATTEMPTED, TO DRAW BACK THE RADIAL ARTERY TOWARDS THE PERFORATOR. THE PHYSICIAN WITHDREW THE ELLIPSYS DEVICE BACK AT LEAST 20MM. DURING THE INITIAL PLACEMENT , RESISTANCE OF THE DEVICE COULD NOT BE 'FELT' IN THE RADIAL ARTERY UPON INITIAL PULLBACK. SEVERAL ATTEMPTS WERE MADE, THE DEVICE WAS NOT ACTIVATED DUE TO NO ¿FEEL¿ OF THE FOOTPLATE WITHIN THE RADIAL ARTERY WAS FELT. THE DEVICE WAS ROTATED TO BETTER VISUALIZE IT UNDER ULTRASOUND. ON THE THIRD ATTEMPT THE PHYSICIAN WITHDREW THE DEVICE FROM THE PATIENT WITH FORCE, AND A LARGE HAEMATOMA WAS FORMED, THE TREATMENT WAS NOT PERFORMED. FASCIOTOMY SURGICAL REPAIR FOR A HEMATOMA WAS PERFORMED.
Patient problems: Hematoma
MAUDE report 18266155 ↗
Other Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access devices
- WavelinQ WQ4300Clearstream Technologies Limited · Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access6 deaths220 reports
- WavelinQ W04200Bard Peripheral Vascular, Inc. · Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access81 reports
- Ellipsys Vascular Access System AMI6005Avenu Medical, Inc. · Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access53 reports
- WavelinQ FX-001CETva Medical, Inc. · Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.