EverCross™ AB35W07150135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169974203), received between Mar 14, 2025 and Sep 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Burst Container or Vessel

  It was reported that during a procedure using an Evercross PTA balloon catheter, for the treatment of a plaque lesion in the mid section of the right superficial femoral artery (vessel diameter; 6.5 mm), the balloon experienced a pinhole type balloon burst (Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure) on the first inflation. The vessel was post- dilated. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. The balloon was inflated with a (Cook Medical) inflation device and 50/50 contrast inflation fluid was used. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The instructions for use were followed without issue. It is not known at what pressure the balloon burst. The balloon did not detach during the procedure. The device was safely removed from the patient. The procedure was completed using a new (Medtronic) device. The patient was reported as alive, with no injury. No injury or intervention was associated with this event. No patient symptoms or complications have been reported as a result of this event. It was reported that there was a 3 minute

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947116 ↗
• MalfunctionMar 14, 2025Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. A 6FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE-DILATED. THE BALLOON PASSED THROUGH A PREVIOUSLY DEPLOYED EVERFLEX STENT. NO RESISTANCE WAS MET. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. IT WAS REPORTED DURING THE SECOND INFLATION THE BALLOON BURST LONGITUDINALLY. IT IS NOT KNOWN AT WHAT PRESSURE THE BALLOON BURST. THE BALLOON DID NOT DETACH AND IT WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER EVERCROSS BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604247 ↗