EverCross™ AB35W06120080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061718), received between Oct 3, 2018 and Oct 3, 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.

• MalfunctionOct 3, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS WITH A NON-MEDTRONIC 5FR SHEATH AND A NON-MEDTRONIC 0.035¿ GLIDEWIRE TO TREAT A SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RIGHT MID PROXIMAL ILIAC ARTERY. THE ARTERY DIAMETER AND LESION LENGTH WERE 8MM AND 90MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT A BALLOON FRACTURE/RUPTURE OCCURRED DURING INFLATION. A PRESSURE OF 8 ATM'S WAS APPLIED TO THE BALLOON PRIOR TO THE RUPTURE. WHILE ATTEMPTING TO REMOVE THE BALLOON, IT BECAME CAUGHT ON THE CALCIFIED PLAQUE. ADDITIONAL FORCE WAS NEEDED TO REMOVE IT THROUGH SHEATH AND THE SHAFT BROKE. THE PHYSICIAN WAS ABLE TO REMOVE THE 5FR SHEATH, WITH THE WIRE REMAINING IN THE PATIENT, AND THE REMAINING PORTION OF THE CATHETER/BALLOON OVER THE WIRE. NO PORTIONS OF THE CATHETER/BALLOON REMAINED IN THE PATIENT. A 6FR SHEATH WAS THEN PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929327 ↗

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