EverCross™ AB35W06080135 (UDI 00763000184421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184421), received between Jun 6, 2023 and Aug 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE EVERFLEX ENTRUST STENT AND ONE EVERCROSS BALLOON WERE USED TO TREAT THE LEFT INTERNAL ILIAC ARTERY. DURING THE INDEX PROCEDURE POST DILATION WAS BEING PERFORMED USING THE EVERCROSS BALLOON TO OPTIMIZE THE LESION DILATION. HOWEVER IT WAS NOTED AT THE SITE THAT A TYPE A DISSECTION OCCURRED DURING THIS POST DILATION WITH THE EVERCROSS BALLOON. NO TREATMENT WAS PERFORMED TO TREAT THIS DISSECTION SUCH AS PROVISIONAL STENTING OR ADDITIONAL BALLOONING. IT WAS STATED THAT THERE WAS NO INDICATION THAT THE EVERFLEX ENTRUST STENT CAUSED OR CONTRIBUTED TO THE DISSECTION AND THE STENT WAS SUCCESSFUL AND THE STENTING PROCEDURE DID NOT RESULT IN A GEOGRAPHIC MISS. PROCEDURAL RESULTS SHOWED GOOD INFLOW AND OUTFLOW, NO PERFORATION OCCURRED DURING THE PROCEDURE AND THE RESIDUAL STENOSIS AFTER ALL INTERVENTIONS WERE COMPLETE DECREASED FROM PRE-PROCEDURE OF 80% TO 25% AT PROCEDURE CONCLUSION.

  Patient problems: Vascular Dissection

  MAUDE report 17448527 ↗
• MalfunctionJun 6, 2023Leak/Splash; Leak/Splash

  AN EVERCROSS PTA BALLOON WAS INTENDED TO BE USED DURING TREATMENT OF LOWER EXTREMITY ARTERIAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO DAMAGE NOTED TO PACKAGING NOTED, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE EVERCROSS LEAKED AT FROM THE BALLOON 8ATM. THE PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070376 ↗