EverCross™ AB35W06100080Recalls & reported problems
Ev3, Inc · PTA AB35W06100080 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061688), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 injury.
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
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryMar 27, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON TO TREAT AN AV FISTULA. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED WITH PER IFU WITH NO ISSUES. SIX INFLATIONS WERE PERFORMED. IT WAS REPORTED THAT DURING BALLOON INFLATION TO 18ATM THE BALLOON BURST. DURING REMOVAL OF THE DEVICE FROM THE PATIENT, THE DISTAL MARKER DETACHED FROM THE DEVICE AND REMAINED IN THE PATIENT. THE BALLOON WAS REMOVED FROM THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem
MAUDE report 8455172 ↗
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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