EverCross™ AB35W07080135Recalls & reported problems
Ev3, Inc · PTA AB35W07080135 EVERCROSS 035 V05 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061893), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K103322); they may or may not involve this specific model.
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
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2019Inflation Problem; Inflation Problem
THE PHYSICIAN INTENDED TO USE THE EVERCROSS BALLOON WAS TO BE USED TO TREAT A LESION IN THE LEFT MID SFA. NO DAMAGE WAS NOTED TO PACKAGING, NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, NO STENT INTERACTION WAS REPORTED, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO INFLATE THE BALLOON WHILST IN THE PATIENT, IT IS UNKNOWN WHERE THE LEAK IS ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8381446 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103322. One submission often covers many models, so check the product and lot details in each record.
- Z-1489-2014 · Apr 9, 2014 · Terminatedev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W
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- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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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