EverCross™ AB35W07200135 (UDI 00821684061978)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061978), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN ATTEMPTED TO USE AN EVERCROSS BALLOON TO TREAT A SEVERELY CALCIFIED LESION WITH CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID- SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL PRESENTED MODERATE TORTUOSITY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A PIN HOLE BALLOON BURST DURING INFLATION TO 8 ATM. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149943 ↗

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