EverCross™ AB35W06120135 (UDI 00643169973978)Recalls & reported problems
Ev3, Inc · PTA AB35W06120135 EVERCROSS 035 V08 · 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 00643169973978), received between Nov 1, 2024 and Nov 1, 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 1, 2024Burst Container or Vessel; Burst Container or Vessel
TWO EVERCROSS PTA BALLOONS WERE USED DURING TREATMENT OF A 150MM CALCIFIED LESION WITH 60% STENOSIS IN THE PROXIMAL REGION OF THE LEFT IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION AND TORTUOSITY. A 6FR NON MEDTRONIC SHEATH AND A 0.035" NON MEDTRONIC GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A 4X100 NANOCROSS AND A TURBOHAWK PLUS. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. AN UNKNOWN INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. IT WAS REPORTED FOR BOTH BALLOONS ON THE FIRST INFLATION, THE BALLOON BURST AT 8ATM. THE BALLOON DID NOT DETACH. THE TYPE OF BALLOON BURST IS NOT KNOWN. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A 6X80MM EVERCROSS WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20585683 ↗
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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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