EverCross™ AB35W09060080 (UDI 00763000184926)Recalls & reported problems
Ev3, Inc · PTA AB35W09060080 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 00763000184926), received between Jan 13, 2026 and Jan 13, 2026 — 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.
MalfunctionJan 13, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W09060080 EVERCROSS 035 BALLOON, A PIN HOLE BALLOON BURST OCCURRED ON THE FIRST INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051792 ↗
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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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