EverCross™ AB35W10040135 (UDI 00821684062265)Recalls & reported problems
Ev3, Inc · PTA AB35W10040135 EVERCROSS 035 V05 · Class 2
Data updated Oct 13, 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 00821684062265), received between Jun 7, 2018 and Jun 7, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2018Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS USING AN EVERCROSS BALLOON WITH A NON-MEDTRONIC 8F SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE FOR TREATMENT OF A 200 MM, 70% (STENOSED) SOFT TISSUE CLOT IN THE PATIENT¿S MID LEFT COMMON FEMORAL VEIN. THE VESSEL DIAMETER WAS REPORTED TO BE BETWEEN 16-18 MM. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH ISOVUE AND SALINE 1:3. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED WHEN ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE BALLOON BURST AT A PRESSURE OF 9 ATMS FOR 10 SECONDS ON FIRST INFLATION. THE BALLOON FRAGMENTS WERE RETRIEVED WITH CYSTOGRASPERS AND NON MEDTRONIC CATHETERS WERE PLACED BILATERALLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7577667 ↗
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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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