EverCross™ AB35W05020135Recalls & reported problems
Ev3, Inc · PTA AB35W05020135 EVERCROSS 035 V09 · 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 00763000184087), received between Oct 7, 2019 and Oct 7, 2019 — 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
- Detachment of Device or Device Component1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 7, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
PHYSICIAN USED EVERCROSS PTA BALLOON CATHETER ALONG WITH NON MEDTRONIC 7FR SHEATH AND .035 GUIDE WIRE TO TREAT A NONE CALCIFIED SOFT TISSUE LESION IN THE RIGHT PROXIMAL ILIAC COMMON ARTERY. THE VESSEL DIAMETER WAS 8MM AND SEVERELY TORTUOUS. NEGATIVE PREP WAS PERFORMED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON WAS USED TO TREAT THE AORTIC BIFURCATION TO HELP CROSSOVER KISSING STENTS. THE BALLOON WAS INFLATED TO 6-7ATM AND IT BURST. THE BALLOON IS THOUGHT TO HAVE GONE THROUGH A STENT STRUT AND UPON REMOVAL WAS CAUGHT ON STRUT. MAKE AND MODEL OF PREVIOUSLY DEPLOYED STENT IS UNKNOWN. THE BALLOON TIP WAS DETACHED DURING REMOVAL AND SNARE USED TO REMOVE DETACHED COMPONENT.
Patient problems: Injury
MAUDE report 9162008 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page