EverCross™ AB35W09040080 (UDI 00763000184902)Recalls & reported problems
Ev3, Inc · PTA AB35W09040080 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 00763000184902), received between Sep 16, 2020 and Sep 16, 2020 — 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
- 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.
MalfunctionSep 16, 2020Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A FIBROUS AV FISTULA IN PROXIMAL RIGHT LOCATION. SLIGHT VESSEL TORTUOSITY IS REPORTED. 80% STENOSIS IS REPORTED. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH THE DEVICE FOR BALLOON INFLATION. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON BURST AT 10ATM IS REPORTED. THE BALLOON WAS FULLY RETRIEVED FROM THE PATIENT. A DIFFERENT MEDTRONIC BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10540641 ↗
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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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