EverCross™ AB35W06030135 (UDI 00763000184346)Recalls & reported problems
Ev3, Inc · PTA AB35W06030135 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000184346), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 death.
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
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 1, 2021Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT'S LEFT COMMON ILIAC ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A BALLOON BURST IS REPORTED. THE DEVICE HAD TO BE SURGICALLY REMOVED FROM THE PATIENT'S ARTERY. THE PATIENT IS NOW DECEASED, THE PATIENT HAD A MYOCARDIAL INFARCTION DAYS AFTER THE CASE.
Patient problems: Myocardial Infarction
MAUDE report 12726450 ↗
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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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