EverCross™ AB35W09040080 (UDI 00821684062159)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684062159), received between Jun 27, 2018 and Jan 7, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH SALINE AND CONTRAST SOLUTION. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A BURST/RUPTURE OCCURRED DURING BALLOON INFLATION WHILE THE DEVICE WAS IN THE PATIENT. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED BY SURGICAL PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8221535 ↗
• MalfunctionSep 20, 2018Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  THE PHYSICIAN WAS ATTEMPTING TO USE A EVERCROSS WITH A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC 0.035" GLIDEWIRE TO TREAT A 25MM FIBROUS LESION WITH 75% STENOSIS IN THE MID ATERIAL/VENOUS GRAFT OF DIAMETER 9MM. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH A 50/50 MIXTURE OF CONTRAST AND NORMAL SALINE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO 11 ATM AND RUPTURED. IT APPEARS THAT IT WAS A LONGITUDINAL CRACK. ALL OF THE BALLOON WAS REMOVED FROM THE PATIENT AND NONE WAS LEFT BEHIND IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A FORTREX BALLOON, OF THE SAME SIZE, WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7892980 ↗
• DeathJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IN THIS INCIDENT HAD A TOTAL RIGHT PROXIMAL TO MID ILIAC OCCLUSION THAT WAS APPROACHED RETROGRADE ON THE RIGHT SIDE. THE VESSEL WAS PRE-DILATED. THE TARGET LESION WAS A CTO (CHRONIC TOTAL OCCLUSION-100%) WITH SEVERE CALCIFICATION. THE VESSEL WAS MODERATELY TORTUOUS. A VIANCE CATHETER WAS INITIALLY USED TO TRY AND CROSS THE LESION BUT WENT SUB-INTIMAL AND POTENTIALLY OUTSIDE THE VESSEL IN THIS ATTEMPT BELOW THE OCCLUSION. A GUIDE WIRE AND RE-ENTRY CATHETER WERE USED SUCCESSFULLY TO EVENTUALLY NAVIGATE PAST THE LESION AND RE-ENTER THE ILIAC. TREATMENT TO THE PROXIMAL RIGHT ILIAC THEN WAS ORIGINALLY APPROACHED WITH THE THOUGHT IN MIND OF USING A PROTÉGÉ GPS ON THE OSTIAL AND PROXIMAL ILIAC WITH THE GOAL OF NOT COMPROMISING OR JAILING THE INTERNAL ILIAC. A 10X80 PROTÉGÉ GPS WAS DEPLOYED SUCCESSFULLY. AN EVERFLEX 8X80 WAS USED TO TREAT A STENOSIS ON THE LEFT ILIAC SUCCESSFULLY AS WELL. IT WAS THEN NOTED THE PATIENT¿S BLADDER LOOKED COMPRESSED, A TYPICAL SIGN OF AN INTERNAL BLEEDING SITUATION. A NON-MDT COVERED STENT WAS PLACED DISTAL TO THE 10X 80 PROTÉGÉ IN THE RIGHT ILLIAC WHERE THE BLEED APPEARED TO BE AND THIS SEEMED TO RESOLVE THE ISSUE. UPON FURTHER EXAMINATION OF THE

  Patient problems: Death; Perforation

  MAUDE report 7640849 ↗

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