EndoAVF® Access Kit 10884450412081Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450412081), received between Jun 23, 2021 and Feb 15, 2022 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2022Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THAT DURING A FISTULA PROCEDURE THE CLINICIAN WAS ATTEMPTING TO USE THE ELLIPSYS DEVICE DURING FISTULA PROCEDURE. IT WAS ALLEGED THERE WAS NO VESSEL TORTUOSITY, THE ARTERY DIAMETER WAS 2.5MM AND VEIN DIAMETER WAS 3MM. THE DISTANCE BETWEEN ARTERY AND VEIN WAS NOT GREATER THAN 1.5MM. IFU WAS FOLLOWED. IT IS ALLEGED THAT DURING THE PROCEDURE WHILE THE CATHETER WAS BEING PULLED BACK ACROSS THE ANASTOMOSIS, IT DID NOT CATCH ON THE ARTERIAL WALL AND WAS RETRACTED INTO THE VEIN AT WHICH POINT IT BECAME STUCK. NEITHER THE CATHETER NOR THE SHEATH WOULD ADVANCE OR RETRACT. THE CATHETER WAS ROTATED AND AT ONE POINT CLOSED TO TRY AND HELP ADVANCE OR RETRACT, BUT WAS UNSUCCESSFUL. THE CLINICIAN USED FORCE TO REMOVE THE CATHETER AND SHEATH TOGETHER WHILE MAINTAINING WIRE ACCESS. IT IS BELIEVED THE CATHETER MAY HAVE BECOME STUCK ON A VALVE IN THE PERFORATING VEIN. THE ACCOUNT ALLEGES THAT THE DEVICE WAS STUCK AROUND THE OUTSIDE OF THE SHEATH AND BOTH HAD TO BE REMOVED TOGETHER. A SMALL HEMATOMA FORMED AND A SLIGHTLY LARGER EXIT HOLE WAS CREATED IN THE ANTERIOR VEIN WALL. THIS WAS RESOLVED WITH PROLONGED PRESSURE HOLD AND A SUTURE AT THE SKIN ENTRY POINT. A NEW CATHETER AND SHE

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 13538920 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT SIGNIFICANT EXTRAVASATION OF BLOOD FLOW OCCURRED DURING USE OF AN ELLIPSYS CATHETER FOR PATIENT TREATMENT. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE PERFORATOR VEIN BEFORE PUNCTURING THE RADIAL ARTERY. THE PATIENT REQUIRED AN OPEN INCISION TO REPAIR THE BLOOD FLOW OUTSIDE OF THE VESSEL AND HAD A SURGICAL BRACHIOBASILIC AVF SUCCESSFULLY CREATED. THE PATIENT REQUIRED OBSERVATION OVERNIGHT. ONCE THE PATIENT WAS STABLE, THE PATIENT WAS RELEASED HOME. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12397087 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS ATTEMPT ON A PATIENT DIAGNOSED WITH CORONARY ARTERY DISEASE [CAD], THE PATIENT SUFFERED A VASOVAGAL EFFECT AND CODED AS THE PHYSICIAN STUCK THE PATIENT WITH THE ACCESS NEEDLE. A CODE WAS CALLED BY THE MEDICAL STAFF AND HOSPITAL PROTOCOLS WERE INITIATED. THE PATIENT RECOVERED AND IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050064 ↗