EverCross™ AB35W08040080 (UDI 00821684062043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684062043), received between Dec 6, 2017 and Dec 7, 2018 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K103322); they may or may not involve this specific model.

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.

• InjuryDec 7, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN USED AN EVERCROSS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION. ALL FRAGMENTS OF THE BALLOON WERE REMOVED FROM PATIENT AND THE PROCEDURE WAS COMPLETED USED ANOTHER BALLOON. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141395 ↗
• MalfunctionDec 6, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON-EXPANDABLE STENT TO TREAT A 20 CM SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND THE LESION HAD 90% STENOSIS. THE ARTERY DIAMETER WAS 7.67MM. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THE VISI-PRO WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING AN 4X4X40 EVERCROSS PTA BALLOON WITHOUT DIFFICULTY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING THE FIRST INFLATION AT 8 ATMS, THE STENT BALLOON BURST LONGITUDINALLY. THE VESSEL WAS SUCCESSFULLY STENTED USING THE VISI-PRO BALLOON-EXPANDABLE STENT, DESPITE RUPTURE OF THE STENT BALLOON. THE FRACTURED BALLOON WAS REMOVED, AND NO INTERVENTION WAS REQUIRED TO REMOVE ANY BALLOON PARTICULATES. THE LESION WAS THEN POST-DILATED WITH THE 8X40 EVERCROSS PTA BALLOON. THERE WAS RUPTURE WITH THIS BALLOON AS WELL DURING INFLATION. THE BALLOON WAS REMOVED, AND NO INTERVENTION WAS REQUIRED TO REMOVE BALLOON FRAGMENTS. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103322. One submission often covers many models, so check the product and lot details in each record.

• Z-1489-2014 · Apr 9, 2014 · Terminated
  ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W