EverCross™ AB35W06120135 (UDI 00763000184476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000184476), received between Mar 9, 2021 and Jun 21, 2024 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJun 21, 2024Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  PHYSICIAN INTENDED TO USE AN EVERCROSS 035 PTA BALLOON WITH A 6FR SHEATH AND A 0.035 GUIDEWIRE DURING TREATMENT OF A 120MM FIBROUS LESION IN THE PATIENTS RIGHT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED WITH NO ISSUES NOTED DURING INFLATION. CONTRAST INFLATION FLUID WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. DEFLATION TOOK 40 SECONDS. A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCC URRED AT 7 ATMS. NO VESSEL INJURY NOTED. A REPLACEMENT NON-MEDTRONIC BALLOON OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581506 ↗
• InjuryMar 9, 2021Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FE MORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON GOT RUPTURED IN SFA, HALF OF THE BALLOON GOT STUCK DUE TO THE CALCIUM IN THE VESSEL, TWO PHYSICIANS TRIED TO SNARE IT OUT, BUT WAS UNSUCCESSFUL. FINALLY CONTRAST RUN WAS DONE AND PATIENT HAD GOOD FLOW, FOR THAT REASON, PHYSICIAN DID NOT BYPASS THE PATIENT. PATIENT WAS SENT TO ANOTHER HOSPITAL TO KEEP AN EYE ON AS NO VASCULAR SURGEON WAS ON CALL AT THE TREATMENT FACILITY. PHYSICIAN DID NOT DO ANY DATIX ON THIS INCIDENT, AS THIS WAS NOT AN AVOIDABLE INCIDENT DUE TO CALCIUM, BALLOON GOT STUCK. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11445791 ↗