EverCross™ AB35W10060135 (UDI 00821684062289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684062289), received between Mar 1, 2019 and Mar 1, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 1, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS 035 BALLOON DILATATION CATHETER TO TREAT A LESION IN THE PROXIMAL COMMON ILIAC ARTERY WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY WITH 85% STENOSIS. ARTERY DIAMETER REPORTED AS 10MM, LESION LENGTH 50MM. A NON-MEDTRONIC 7FR SHEATH AND 0.035 GUIDEWIRE WERE ALSO USED. NO DAMAGE NOTED TO PACKAGING NOTED, NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY, DEVICES WAS PREPPED AS PER IFU. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT 9ATMS DURING SECOND INFLATION. RESISTANCE WAS NOT ENCOUNTERED, NO EXCESSIVE FORCED USED. THERE WAS NO INTERVENTION REQUIRED TO REMOVE THE BALLOON FRAGMENTS AND NO VESSEL DAMAGE. A NEW BALLOON WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381672 ↗

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