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EverCross™ AB35W04040135 (UDI 00821684061183)Recalls & reported problems

Ev3, Inc · PTA AB35W04040135 EVERCROSS 035 V05 · Class 2

All models of EverCross (114)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061183), received between Mar 12, 2020 and Mar 12, 2020 — 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

Device problems

  • Burst Container or Vessel1
  • Difficult to Advance1
  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 12, 2020Burst Container or Vessel; Difficult to Advance; Positioning Problem; Burst Container or Vessel; Difficult to Advance; Positioning Problem

    PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SFA WITH 70% STENOSIS. NEGATIVE PREP WAS PERFORMED. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON CATHETER DID NOT GO UP ALONG THE WIRE. IT WAS REPORTED THAT DURING BALLOON INFLATION BALLOON BURST OCCURRED AT AN UNKNOWN ATM. ALL BALLOON FRAGMENTS OF THE BALLOON WERE RETRIEVED. A NEW EVERCROSS PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9823275 ↗

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

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page