EverCross™ AB35W07040135 (UDI 00763000184599)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184599), received between Sep 2, 2020 and Sep 2, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

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.

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.

• MalfunctionSep 2, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" J-WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WERE 7MM AND 30MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 50/50 CONTRAST WAS USED AS INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON CIRCUMFERENTIAL/RADIAL BURST OCCURRED AT 8ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. BALLOON WAS PLACED ACROSS THE LESION AND DURING INFLATION RUPTURED. ALL PARTS OF THE BALLOON WERE REMOVED AND NO VESSEL INJURY WAS NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO INTERVENTION WAS NEEDED, AS ALL PARTS OF BALLOON WERE STILL OK BALLOON CATHETER. DEVICE WAS SAFELY REMOVED FROM PATIENT. TWO INFLATIONS WERE APPLIED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412627 ↗
• MalfunctionMar 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS PTA BALLOON ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND 0.014" NITREX GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 75% STENOSIS. THE VESSEL IS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 30MM RESPECTIVELY. A NON-MEDTRONIC DEVICE WAS USED FOR INFLATION. A 60 SALINE/40 CONTRAST WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, THE BALLOON BURST AT 12ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. PHYSICIAN WAS POST DILATING A STENT PLACED. THE BALLOON WAS INFLATED TO 12 ATM WHEN IT RUPTURED. THE BALLOON WAS THEN TAKEN OUT AND A 7 X 20 EVER CROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO VESSEL DAMAGE NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575437 ↗
• InjurySep 2, 2020Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30MM FISTULOGRAM IN THE PATIENT¿S MID RIGHT CEPHALIC VEIN. SLIGHT VESSEL TORTUOSITY IS REPORTED. VESSEL DIAMETER REPORTED AS 7MM. LESION EXHIBITED 50% STENOSIS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH A 25% CONTRAST: 75% SALINE MIX. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 13ATM. ONE PRIOR INFLATION HAD BEEN APPLIED TO THE DEVICE. IT IS REPORTED DURING REMOVAL THE BALLOON BECAME STUCK AND A PART OF THE BALLOON AND TIP OF THE CATHETER BROKE OFF AND BECAME STUCK WHERE THE CEPHALIC VEIN BIFURCATES INTO THE CEPHALIC IMBECILIC. A TOURNIQUET WAS APPLIED TO THE UPPER ARM AND AN OPEN INCISION WAS MADE TO REMOVE THE PIECE A BALLOON AND CATHETER. THE PATIENT IS REPORTED TO BE DOING WELL AND NO OTHER INJURY WAS REPO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481548 ↗