EverCross™ AB35W06040135 (UDI 00643169973879)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169973879), received between May 23, 2023 and Apr 11, 2024 — 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.

• MalfunctionApr 11, 2024Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS 035 PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN A PATIENT. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED WITH A NANOCROSS ELITE PTA BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A BALLOON BURST DURING PROCEDURE WAS REPORTED. BURST OCCURRED ON FIRST INFLATION. THE BALLOON DID NOT DETACH DURING THE EVENT. INFLATION DIFFICULTIES WERE ALSO REPORTED. NO LEAKS WERE NOTED ON DEVICE. A SECOND EVERCROSS 035 PTA BALLOON WAS ATTEMPTED TO BE USED. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE SECOND EVERCROSS 035 PTA BALLOON WAS UNABLE TO CROSS LESION. A NANOCROSS ELITE PTA BALLOON WAS SUCCESSFUL IN CROSSING LESION AND WAS USED TO COMPLETE PROCEDURE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086455 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A LESION IN THE PATIENT¿S DISTAL LEFT ARTERY/VEIN. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST DURING INFLATION IS REPORTED AT 10ATM. A SECOND EVERCROSS PTA BALLOON WAS ATTEMPTED TO BE USED BUT A LONGITUDINAL BALLOON BURST DURING INFLATION ALSO OCCURRED. THE BALLOONS DID NOT FRAGMENT AND NO INTERVENTION WAS REQUIRED TO REMOVE. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. NO VESSEL INJURY NOTED. PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983252 ↗