EverCross™ AB35W10040080 (UDI 00821684062258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684062258), received between Dec 14, 2017 and May 15, 2018 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS DEVICE WITH A 7FR SHEATH AND NON-MDT 0.035 ANGLED GUIDEWIRE DURING THE TREATMENT OF A MODERATELY CALCIFIED FIBROUS LESION IN THE MID RIGHT SUBCLAVIAN VEIN. IT WAS REPORTED THAT THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS ALSO REPORTED THAT DURING THE SECOND INFLATION OF THE BALLOON, AT AN INFLATION PRESSURE OF 10 ATM, THE BALLOON BURST. FOLLOWING THIS, THERE WERE DIFFICULTIES REMOVING THE BALLOON AS THE TIP OF THE BALLOON CATHETER BROKE OFF. THE BROKEN TIP WAS STUCK TO THE WIRE AND HAD TO BE SNARED FOR REMOVAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513950 ↗
• InjuryFeb 15, 2018Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON DURING AN UPPER EXTREMITY FISTULOGRAM. THE PHYSICIAN FIRST DILATED THE BALLOON TO NOMINAL PRESSURE WITH LACK OF RESOLUTION OF THE STENOSIS. IT WAS REPORTED THE BALLOON WAS THEN DILATED TO LESS THAN BURST-PRESSURE AND THE BALLOON RUPTURED IN THE MIDLINE IN A TRANSVERSE MANNER (NOT ALONG THE LONG AXIS OF THE BALLOON). THERE WERE 2 FREE ENDS OF THE BALLOON STILL LOCATED ON THE TREATMENT WIRE. THE BALLOON COULD NOT BE REMOVED THROUGH THE SHEATH. A SNARE CATHETER WAS ADVANCED TO THE END OF THE MOST CENTRAL END OF THE BALLOON, WHILE KEEPING ON THE WIRE, AND THE ENTIRE SYSTEM, INCLUDING THE SHEATH, WAS WITHDRAWN OVER THE WIRE. THE PROCEDURE THEN PROCEEDED, AND THE PATIENT WAS TREATED WITHOUT RUPTURE OF THE VESSEL. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7275185 ↗
• InjuryDec 14, 2017Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN EVERCROSS PTA BALLOON WAS USED FOR AN ANGIOPLASTY PROCEDURE. IT WAS REPORTED A BALLOON BURST OCCURRED. IT WAS NOT POSSIBLE TO RETRACT THE DEFLATED BALLOON THROUGH THE SHEATH. DUE TO THIS ISSUE, THE PHYSICIAN HAD TO PUNCTURE THE BALLOON SUBCUTANEOUSLY. AFTER REMOVAL OF THE SHEATH, THE USER OBSERVED THAT THE MAIN PART OF THE BALLOON WAS DETACHED FROM THE WIRE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7116280 ↗