EverCross™ AB35W05060135 (UDI 00643169973671)Recalls & reported problems
Ev3, Inc · PTA AB35W05060135 EVERCROSS 035 V08 · 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 00643169973671), received between Nov 5, 2020 and Nov 5, 2020 — 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
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2020Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR SHEATH DURING TREATMENT A 60MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY. ARTERY DIAMETER REPORTED AS 8MM. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC (EPIC) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THAT A BALLOON BURST OCCURRED ON FIRST INFLATION OF THE DEVICE. THE BALLOON WAS SNARED AND SAFELY REMOVED FROM THE PATIENT. NO FRAGMENTS REMAIN IN THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10792094 ↗
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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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