EverCross™ AB35W06040135 (UDI 00763000184377)Recalls & reported problems
Ev3, Inc · PTA AB35W06040135 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 00763000184377), received between Apr 6, 2021 and Apr 6, 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.
MalfunctionApr 6, 2021Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A SPIDER FX AND 7FR NON-MEDTRONIC SHEATH, DURING TREATMENT OF A 40MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON ILIAC ARTERY. ARTERY DIAMETER REPORTED AS 6MM. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION REPORTED. LESION EXHIBITED 75% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH SALINE AND CONTRAST FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DISTAL PORTION OF THE BALLOON WAS IN A PREVIOUSLY DEPLOYED STENT (IMPLANTED GREATER THAN 1 YEAR AGO). RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. THE PHYSICIAN ATTRIBUTED THE ADVANCEMENT DIFFICULTY TO BE DUE TO USING A 0.035 BALLOON OVER A 0.014 WIRE. RESISTANCE WAS NOT FELT IN RELATION TO ADVANCEMENT INTO STENT BUT IN PROXIMAL SEGMENT OF DISTAL EXTERNAL ILIAC/COMMON FEMORAL ARTERY. IT IS REPORTED DURING FIRST INFLATION THE BALLOON BURST AT 6ATM. THE BALLOON WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11618681 ↗
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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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