EverCross™ AB35W08040080 (UDI 00763000184797)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184797), received between Sep 20, 2021 and Jul 2, 2023 — classified as 1 injury, 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. 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.

• MalfunctionJul 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERCROSS TO TREAT A LESION IN THE ILIAC ARTERYCOMMON. EMBOLIC PROTECTION WAS NOT USED. A BOSTON SCIENTIFIC INFLATION DEVICE WAS USED. SALINE & CONTRAST INFLATION FLUID WAS USED. DEVICE WAS PREPPED PER IFU. DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. PROCEDURE COMPLETED WITHOUT INCIDENT. POST PROCEDURE IT WAS REALISED THAT AN EXPIRED EVERCROSS WAS USED. NO ADVERSE EVENTS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244487 ↗
• InjuryJan 7, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS PTA BALLOON WITH A 7FR SHEATH DURING A FISTULOPLASTY. EMBOLIC PROTECTION WAS NOT  USED. 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 DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A CIRCUMFERENTIAL/RADIAL BALLOON BURST IS REPORTED DURING BALLOON INFLATION AT 16MM HG ON FIRST INFLATION. RUPTURE OCCURRED WITHIN THE FISTULA VEIN DURING INFLATION. THE PHYSICIAN HAD TO INSERT A RETROGRADE 8FR SHEATH TO SNARE THE GUIDEWIRE THROUGH, THEN EVENTUALLY MANAGED TO INSERT A LONG 8FR SHEATH FROM THE RETROGRADE ACCESS TOWARDS THE ANTEGRADE ACCESS TO PUSH THE RETAINED BALLOON OUT, WITH MUCH DIFFICULTIES. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13189761 ↗
• MalfunctionSep 20, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON BURST BEFORE REACHING ITS RBP. THE DEVICE WAS SUCCESSFULLY REMOVED FROM PATIENT. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496259 ↗