EverCross™ AB35W04120135 (UDI 00763000184018)Recalls & reported problems
Ev3, Inc · PTA AB35W04120135 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 00763000184018), received between Feb 9, 2021 and Feb 9, 2021 — 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.
MalfunctionFeb 9, 2021Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE A EVERCROSS FOR PATIENT TREATMENT ON THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MID LESION WAS SEVERELY CALCIFIED AND NO TORTUOSITY. CHRONIC TOTAL OCCLUSION OF 100% LESION STENOSIS REPORTED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING NOR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. A BALLOON BURST WAS REPORTED TO OCCUR DURING BALLOON INFLATION AT 8 ATM. THE BALLOON DID NOT FRAGMENT. NO INTERVENTION WAS REQUIRED FOR REMOVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A BALLOON OF THE SAME SIZE, USED TO BALLOON AND PLACE A STENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11299974 ↗
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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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