EverCross™ AB35W03020135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684060964), received between Apr 26, 2018 and Apr 26, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS BALLOON TO TREAT A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION(CTO) IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. THE VESSEL WAS DESCRIBED AS VERY TORTUOUS. THE ARTERY DIAMETER WAS REPORTED AS 7MM AND THE LESION LENGTH OF 30MM. IT WAS REPORTED THE PROCEDURE COMMENCED AFTER BILATERAL FEMORAL SHEATHS HAD BEEN INSERTED. ACCESS WAS GAINED INTO THE ART ANCILLARY ARTERY WHILE A LONG 7MM PTA CATHETER WAS INFLATED IN THE RIGHT ILIAC & DISTAL AORTA. THE PHYSICIAN ATTEMPTED TO CROSS THE LEFT ILIAC ARTERY TO TREAT THE CTO USING BOTH AXILLARY APPROACH. THE PHYSICIAN USED A NON-MEDTRONIC CROSSING DEVICE FROM BOTH APPROACHES. THE GUIDEWIRE CROSSED THE CTO, THE LESION WAS TREATED WITH A 3 X 20 EVERCROSS BALLOON WITH NO EXCESSIVE FORCE USED HOWEVER RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. THE DEVICE HAD BEEN REPORTED TO HAVE BEEN PREPARED PER THE IFU. AFTER THE LESION WAS BALLOONED VIA THE AXILLARY ACCESS SITE, THE EVERCROSS WAS REMOVED FROM THE PATIENT. IT WAS THEN NOTICED THAT THE CATHETER WAS BROKEN, TWO BALLOON MARKERS WERE STILL AT THE INITIAL INFLATION SITE. THE PHYSICIAN ATTEMPTED ON NUMEROUS OCCASIONS TO PUSH THE BROKEN CAT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7463675 ↗

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