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EverCross™ AB35W06200080Recalls & reported problems

Ev3, Inc · PTA AB35W06200080 EVERCROSS 035 V08 · 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 00643169974005), received between Apr 24, 2023 and Apr 24, 2023 — classified as 1 malfunction.

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

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

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

    A PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON FOR TREATMENT OF THE COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. INFLATION FLUID USED WAS 50 CONTRAST 50 HEPARINIZED SALINE. IT WAS REPORTED THE BALLOON WAS INFLATED USING AN UNKNOWN INFLATION DEVICE, AT 14 ATM THE BALLOON BURST. THE TYPE OF BURST IS NOT KNOWN. ANOTHER BALLOON WAS USED. NO VESSEL INJURY NOTED. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16801180 ↗

Other Catheter, percutaneous devices

All Catheter, percutaneous devices →

Sources and updates

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