EverCross™ AB35W06020135 (UDI 00763000184322)Recalls & reported problems
Ev3, Inc · PTA AB35W06020135 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000184322), received between Nov 8, 2021 and Nov 8, 2021 — classified as 1 injury.
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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE BILIARY ARTERY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS A BALLOON BURST/LEAK DURING BALLOON INFLATION AT 14 ATMS AFTER 1 INFLATION. THERE WAS ALSO A BALLOON FRACTURE/BREAK OFF REPORTED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY REMOVING THE BALLOON AND SNARING THE FRACTURED PART OF THE BALLOON. PATIENT OUTCOME UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12770396 ↗
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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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