EverCross™ AB35W08080080 (UDI 00821684062098)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684062098), received between Nov 1, 2016 and Dec 21, 2016 — classified as 2 injuries.

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. 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.

• InjuryDec 21, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN EVERCROSS BALLOON CATHETER DURING PROCEDURE FOR TREATMENT OF THE COM/EXTERNAL ILIAC. THE LESION WAS CALCIFIED. IT IS REPORTED THAT THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY. THE PATIENT WAS TREATED WITH SELF EXPANDED STENT AND THE EVERCROSS BALLOON WAS THEN USED. DURING PROCEDURE, IT IS REPORTED THAT THE BALLOON DETACHED AND LODGED IN THE DISTAL AORTA, AT THE LEFT ILIAC ARTERY. THE PATIENT REQUIRED SURGERY FOR EXTRACTION OF THE BALLOON. IT IS REPORTED THAT STAFF ARE NOT SURE HOW THE BALLOON DETACHED.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 6192987 ↗
• InjuryNov 1, 2016Positioning Problem

  PATIENT UNDERWENT CORONARY ANGIOGRAPHY. DURING THE PROCEDURE, THE PATIENT DEVELOPED BALLOON BEING LODGED IN THE DISTAL AORTA AT THE LEFT ILIAC ARTERY. PATIENT REQUIRED SURGERY FOR EXTRACTION OF THE BALLOON.

  Patient problems: Foreign Body In Patient

  MAUDE report 6075343 ↗

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