EverCross™ AB35W07100135 (UDI 00763000184667)Recalls & reported problems
Ev3, Inc · PTA AB35W07100135 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 00763000184667), received between Dec 18, 2025 and Dec 18, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- 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.
InjuryDec 18, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB35W07100135 EVERCROSS 035 BALLOON TO POST- DILATE AN 8MM X 7.5CM NON-MEDTRONIC STENT, THE BALLOON RUPTURED AND SUBSEQUENTLY DETACHED FROM THE CATHETER. THE DETACHMENT OCCURRED WHEN TRYING TO REMOVE THE BALLOON AFTER IT BURST. THE DETACHED PORTION OF THE BALLOON BECAME LODGED IN THE RIGHT EXTERNAL ILIAC ART ERY. THE TARGET LESION WAS LOCATED IN THE MID RIGHT COMMON ILIAC ARTERY, CHARACTERIZED BY SEVERE CALCIFICATION, 80% STENOSIS, A LESION LENGTH OF 40MM, AND AN ARTERY DIAMETER OF 8MM. THE VESSEL WAS NOT PRE-DILATED. A 0.035 NON-MEDTRONIC GUIDEWIRE WAS USED. AN INFLATION DEVICE WITH 50/50 CONTRAST INFLATION FLUID WAS USED FOR BALLOON INFLATION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DISLODGED BALLOON PORTION. THE BALLOON CATHETER WAS SAFELY REMOVED HOWEVER PART OF THE DETACHED BALLOON REMAINED IN THE VESSEL AND HAD TO BE TACKED TO THE VESSEL WALL WITH AN ADDITIONAL STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837311 ↗
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