EverCross™ AB35W10060080 (UDI 00763000185022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000185022), received between Nov 26, 2020 and Sep 30, 2024 — classified as 3 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. 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.

• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF AN EVERCROSS PTA BALLOON, THE BALLOON TIP BROKE OFF UPON WITHDRAWING OUT OF THE PATIENT. SURGEON AWARE AND NOTICED IT IMMEDIATELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332950 ↗
• MalfunctionAug 20, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS BALLOON CATHETER DURING PATIENT TREATMENT IN IN AN AV FISTULA ACCESS. MODERATE VESSEL CALC IFICATION IS REPORTED. THE ARTERY DIAMETER WAS 3MM AND LESION LENGTH WAS 60MM. LESION EXHIBITED CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE 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. VESSEL WAS NOT POST DILATED. BALLOON WAS INFLATED USING A SYRINGE IT WAS REPORTED THE BALLOON BURST CIRCUMFERENTIAL/RADIAL DURING PROCEDURE. THE BALLOON FRAGMENTED IN 2 PIECES BUT REMAINED ATTACHED TO THE SHAFT AND DEVICE WAS REMOVED BY SIMPLY REMOVING OVER THE WIRE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. PROCEDURE WAS COMPLETE SUCCESSFULLY USING A NEW DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001447 ↗
• MalfunctionNov 26, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING BALLOON INFLATION. ALL FRAGMENTS OF THE BALLOON WERE REMOVED. THE BALLOON WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911049 ↗