EverCross™ AB35W05100135 (UDI 00763000184223)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184223), received between Nov 5, 2019 and Mar 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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. 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.

• MalfunctionMar 13, 2020Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON FOR TREATMENT OF THE A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 70% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. PRE-DILATION WAS PERFORMED. NO DAMAGE NOTED TO PACKAGING PRIOR TO SUE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THAT THE BALLOON WAS INFLATED TO 5ATM AND THE BALLOON WAS NOT OBSERVED TO HAVE BEEN FILLING. THE PRESSURE PUMP WAS INCREASED TO 8ATM AND THE BALLOON STILL DID NOT APPEAR TO FILL. THE BALLOON WAS DEFLATED FOR WITHDRAWAL AND BLOOD WAS OBSERVED IN THE PRESSURE PUMP. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND A LONGITUDINAL BALLOON BURST WAS EVIDENT. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829080 ↗
• MalfunctionNov 5, 2019Burst Container or Vessel; Inflation Problem; Leak/Splash; Burst Container or Vessel; Inflation Problem; Leak/Splash

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DIAMETER REPORTED AS 4-7MM. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. NO ISSUES NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING TWO BALLOONS. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. WHEN THE BALLOON REACHED THE TARGET AREA, THE BALLOON WAS ATTEMPTED TO BE INFLATED. IT IS REPORTED THAT BALLOON INFLATION WAS NOT OBVIOUS, AND THE PRESSURE PUMP DID NOT MOVE. THE PHYSICIAN WITHDREW THE BALLOON. BLOOD WAS OBSERVED IN THE PRESSURE PUMP. A LEAK IN THE BALLOON WAS ALSO OBSERVED. NO BALLOON FRAGMENTATION REPORTED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278075 ↗