EverCross™ AB35W06060135 (UDI 00821684061640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061640), received between Jun 18, 2019 and Oct 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103322); they may or may not involve this specific model.

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.

• MalfunctionOct 15, 2020Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON ALONG WITH A NON-MEDTRONIC 7FR SHEATH, A SPIDER 0.014" 320CM GUIDE WIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR THE INFLATION OF THE BALLOON. INFLATION FLUID HEPSAL OMNIPAQUE 60/40 WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP./TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING INITIAL BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 10ATM. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. A SECOND EVERCROSS PTA BALLOON WAS ATTEMPTED AND DURING INITIAL INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8ATM. PHYSICIAN USED MEDTRONIC 5X150 AND 6X60 PTA BALLOONS, AND STENTS WERE PLACED WITHIN EX

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10683665 ↗
• MalfunctionJun 18, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS CALCIFIED 60% STENOTIC LESION IN THE PROXIMAL COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, HOWEVER RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. IT WAS REPORTED THAT DURING INFLATION TO 8ATM, A PINHOLE LEAK WAS OBSERVED IN THE BALLOON. ALL FRAGMENTS OF THE BALLOON WERE REPORTED TO HAVE BEEN RETRIEVED. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103322. One submission often covers many models, so check the product and lot details in each record.

• Z-1489-2014 · Apr 9, 2014 · Terminated
  ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W