EverCross™ AB35W09060080 (UDI 00821684062173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684062173), received between Sep 21, 2017 and Sep 21, 2017 — classified as 1 injury.

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. 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.

• InjurySep 21, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN PERFORMED A BILATERAL STENTING PROCEDURE OF BOTH RIGHT AND LEFT COMMON ILIAC ARTERIES WITH UNKNOWN STENTS USING ¿KISSING¿ TECHNIQUE. IT WAS REPORTED THAT POST STENT DEPLOYMENT, THE NEED FOR FURTHER ANGIOPLASTY WAS IDENTIFIED IN THE RIGHT MID COMMON ILIAC ARTERY. THE LESION WAS CALCIFIED AND THE ARTERY HAD LITTLE TORTUOSITY. AN EVERCROSS 9MMX40MM PTA BALLOON WAS USED TO PERFORM THE ANGIOPLASTY PROCEDURE. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED THAT THIS BALLOON BURST ON INFLATION WITHOUT ANY INCIDENT. A SECOND EVERCROSS 9MMX60MM PTA BALLOON WAS SELECTED FOR USE. IT WAS REPORTED THAT A CIRCUMFERENTIAL/ RADIAL BURST OCCURRED DURING INFLATION FOR THIS BALLOON. IT WAS NOTED THAT AN INCH OF THE TIP WAS MISSING. THIS WAS CONFIRMED BY FURTHER IMAGING WHICH DEMONSTRATED THE BROKEN PIECE STILL IN SITU. THE PHYSICIAN HAD TROUBLE IN REMOVING THE FRAGMENTS OF THE BALLOON FROM THE ARTERY. THIS BROKEN TIP COULDN'T BE RETRIEVED VIA SNARE. A SURGICAL INTERVENTION UNDER GENERAL ANESTHESIA WAS REQUIRED TO REMOVE FRAGMENTS. THE SURGERY WAS REPORTED TO BE SUCCESSFU

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6881802 ↗

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