EverCross™ AB35W04080135 (UDI 00643169973473)Recalls & reported problems
Ev3, Inc · PTA AB35W04080135 EVERCROSS 035 V08 · Class 2
Data updated Oct 13, 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 00643169973473), received between Sep 20, 2022 and Nov 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER FOR TREATMENT OF AN UNKNOWN LESION IN THE POPLITEAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING AN EVEREST INFLATION DEVICE. IT WAS REPORTED THAT THE BALLOON BURST/LEAKED AT 6 ATM. ALL FRAGMENTS WERE RETRIEVED. NO INTERVENTION WAS REQUIRED TO RETRIEVE FRAGMENTS. THE SHEATH WAS REMOVED AND THE CLOSURE WAS USED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15859985 ↗MalfunctionSep 20, 2022Burst Container or Vessel; Burst Container or Vessel
IT IS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED EXTERNAL ILIAC TWO BALLOONS BURST OCCURRED. AN EVERCROSS BALLOON BURST BEFORE 20ATM AND A NANOCROSS BALLOON BURST BEFORE 14ATM. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER THE IFU. DEVICE WAS INFLATED WITH AN EVEREST ENDOFLATOR. 3:1 SALINE TO CONTRAST INFLATION FLUID USED. NO EMBOLIC PROTECTION USED. ISSUE OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL TREATMENT REQUIRED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455781 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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