EverCross™ AB35W07060080 (UDI 00763000184612)Recalls & reported problems
Ev3, Inc · PTA AB35W07060080 EVERCROSS 035 V09 · 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 00763000184612), received between Apr 15, 2022 and Apr 15, 2022 — 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
- Inflation Problem1
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 15, 2022Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem
PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID COMMON ILIAC ARTERY WITH 34-35% STENOSIS. THE ABNORMALITY REPORTED IN RELATION TO PATIENT ANATOMY WAS INTERNAL/HYPO IS NON EXISTENT OR COMPLETELY CALCIFIED. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND ROUGHLY 60MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED DURING INFLATION AND BURST OCCURRED AT 14ATM. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A 8X60 EV ERCROSS PTA BALLOON. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14116975 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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