EverCross™ AB35W08080080 (UDI 00763000184841)Recalls & reported problems
Ev3, Inc · PTA AB35W08080080 EVERCROSS 035 V09 · Class 2
All models of EverCross (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184841), received between Dec 7, 2020 and Nov 12, 2024 — classified as 2 malfunctions.
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
- Fracture1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS 035 PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS RIGHT MID COMMON ILIAC ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A BALLOON LEAK WAS REPORTED DURING THE PROCEDURE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT INJURY/INTERVENTION. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663004 ↗MalfunctionDec 7, 2020Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture
PHYSICIAN USED AN EVERCROSS PTA BALLOON DURING PATIENT TREATMENT. IT IS REPORTED THAT DURING THE PROCEDURE THE BALLOON FRACTURED IN THE PATIENT, AND A PORTION HAS BEEN LEFT IN THE PATIENT. THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 10957409 ↗
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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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