EverCross™ AB35W05150135 (UDI 00821684061527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061527), received between Apr 3, 2019 and Oct 11, 2019 — 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.

• MalfunctionOct 11, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A EVERCROSS PTA BALLOON CATHETER AS PART OF A PROCEDURE ON THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LEFT PROXIMAL, SEVERELY CALCIFIED LESION WAS MODERATELY TORTUOUS. THERE WAS 100% LESION STENOSIS (CHRONIC TOTAL OCCLUSION). THE LESION LENGTH WAS 40 CM, WHERE THE ARTERY WAS 6 MM IN DIAMETER. THERE WAS A LONG STENTED SEGMENT THAT WAS APPROXIMATELY 40 CM. A NON-MEDTRONIC 6 FR SHEATH WAS USED . THERE WAS NO EMBOLIC PROTECTION USED WITH THE NON-MEDTRONIC GUIDEWIRE. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE IFU WAS FOLLOWED DURING PREPARATION AND PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN PASSED THE BALLOON THROUGH A PREVIOUSLY DEPLOYED STENT AND ENCOUNTERED RESISTANCE. UPON THE THIRD INFLATION, THE BALLOON CIRCUMFERENTIALLY/RADIALLY BURSTED AT 10 ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. UPON REMOVING THE DEVICE, THE DISTAL RADIOPAQUE MARKER HAD DETACHED AND REMAINED ON THE WIRE. THE WIRE WAS PULLED INTO THE SHEATH AND THE PHYSICIAN REMOVED THE WHOLE SHEATH FROM THE PATIENT. THE PROCEDURE WAS STOPPED AND WILL BE COMPLETED ON ANOTHER TIME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178665 ↗
• InjuryApr 3, 2019Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON TO TREAT A SEVERELY CALCIFIED, SLIGHTLY TORTUOUS LESION, WITH 80% STENOSIS, IN THE MID DISTAL LEFT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 6MM & 130MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. A 6FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE TO 8ATM. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE EVERCROSS BALLOON RUPTURED ON FIRST INFLATION. DIFFICULTIES WERE EXPERIENCED IN REMOVING THE BALLOON SO THE PATIENT WAS TRANSFERRED TO SURGERY FOR A FEMORAL BYPASS AS THE VESSEL WAS OCCLUDED DUE TO THE DEVICE RUPTURE.

  Patient problems: Occlusion; Patient Problem/Medical Problem

  MAUDE report 8477362 ↗

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