EverCross™ AB35W07020135Recalls & reported problems
Ev3, Inc · PTA AB35W07020135 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 00763000184544), received between Nov 7, 2024 and Nov 7, 2024 — 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.
Reports received per month
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.
MalfunctionNov 7, 2024Burst Container or Vessel; Burst Container or Vessel
AN EVERCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A 15-20MM CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT COMMON ILIAC ARTERY. THE ARTERY WAS APPROXIMATELY 7MM IN DIAMETER WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THE IFU WAS FOLLOWED WITHOUT ISSUE. A 6FR NON MEDTRONIC SHEATH AND A 035/260 NON MEDTRONIC GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. AN UNKNOWN INFLATION DEVICE WAS USED WITH 50/50 CONTRAST INFLATION FLUID. IT WAS REPORTED DURING THE FIRST INFLATION AT 10 ATM THE BALLOON BURST. TYPE OF BALLOON BURST IS NOT KNOWN. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NON MEDTRONIC BALLOON (7MMX20MM) WAS USED TO COMPLETE THE CASE. NO INJURY OR INTERVENTION WAS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630128 ↗
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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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