EverCross™ AB35W07200135 (UDI 00643169974227)Recalls & reported problems
Ev3, Inc · PTA AB35W07200135 EVERCROSS 035 V08 · 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 00643169974227), received between Apr 28, 2022 and Apr 28, 2022 — 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
Patient problems
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT'S PROXIMAL COMMON ILIAC ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE IS REPORTED DURING ADVANCEMENT OF THE DEVICE. A CIRCUMFERENTIAL/RADIAL BALLOON BURST IS REPORTED DURING INFLATION AT 12 ATM. NOT ALL BALLOON FRAGMENTS WERE REMOVED FROM THE PATIENT. A 7X120 ENTRUST EVERFLEX STENT WAS USED TO STENT THE BALLOON MATERIAL IN THE ARTERIAL WALL AND POST DILATED WITH A 7X150 PTA BALLOONS. NO FURTHER INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 14239097 ↗
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