EverCross™ AB35W05060080Recalls & reported problems
Ev3, Inc · PTA AB35W05060080 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 00821684061411), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
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 6, 2019Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON WITH A 6FR NON-MEDTRONIC (MERIT) SHEATH DURING TREATMENT OF A 3CM OCCLUSION IN THE AXILLARY VEIN. THERE WAS NO DAMAGE TO THE DEVICE OR THE PACKAGING. NO EMBOLIC PROTECTION WAS USED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING PREPARATION OF THE DELIVERY CATHETER AND NO LEAKS WERE OBSERVED. A NON-MEDTRONIC (MERIT INFLATOR) WAS USED TO INFLATE THE BALLOON. BALLOON INFLATION DIFFICULTIES WERE ENCOUNTERED DURING INFLATION OF THE BALLOON. THE BALLOON WAS UNABLE TO BE INFLATED TO NOMINAL PRESSURE DUE TO THE LEAK. THE BALLOON SUFFICIENTLY DEFLATED TO REMOVE FROM THE PATIENT WITHOUT ISSUE. A PINHOLE LEAK WAS OBSERVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT INJURY REPORTED. PATIENT IS RECEIVING DIALYSIS 3 DAYS PER WEEK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394964 ↗
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™ 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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