EverCross™ AB35W06080135 (UDI 00821684061671)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061671), received between Jan 25, 2018 and Feb 21, 2019 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionFeb 21, 2019Material Rupture; Material Rupture

  THE PHYSICIAN WAS INTENDING TO USE AN EVERCROSS TO TREAT A 60MM SEVERELY CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL COMMON IIIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA). NO TORTUOSITY WAS REPORTED IN ARTERY OF 6.5 ¿ 7.0MM DIAMETER. A 6FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC 0.035 GUIDEWIRE WAS USED. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES NOTED TO THE DEVICE WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES WERE EXPERIENCED AND THE PHYSICIAN HAD TO CONTINUOUSLY DIAL UP THE NON MEDTRONIC INFLATION DEVICE TO MAINTAIN PRESSURE OF 6ATM. A PIN HOLE BALLOON BURST OCCURRED DURING BALLOON INFLATION AT 6ATM USING THE INFLATION DEVICE WITH 40 CONTRAST AND 60 SALINE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE PATIENT. A SECOND EVERCROSS BALLOON WAS USED AND THE SAME ISSUE WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A NON MEDTRONIC 7 X 100 PTA BALLOON. THERE WAS NO PATIENT INJURY AS A RESU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357599 ↗
• InjuryJan 25, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PROCEDURE BEING PERFORMED USED TWO 6X80 MM EVERCROSS PTA BALLOONS TO PRE-DILATE LESIONS IN A PATIENT¿S COMMON ILIAC ARTERIES AT THE SAME TIME. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 30 CM 6 FR NON-MEDTRONIC SHEATH AND A 0.035¿ 260CM NON-MEDTRONIC GUIDEWIRE. THE EVERCROSS DILATIONS IN THE COMMON ILIAC ARTERIES INFLATED WITHOUT INCIDENT. TWO VISIPRO BALLOON EXPANDABLE STENTS WERE THEN DEPLOYED WITHOUT INCIDENT IN EACH OF THE ILIAC ARTERIES. ONE OF THE 6X80 MM EVERCROSS BALLOONS WAS THEN USED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE LESION WAS 80 MM IN LENGTH AND SEVERELY CALCIFIED (RESULTING IN 70% STENOSIS). THE ARTERY WAS 6 MM IN DIAMETER AND HAD LITTLE TORTUOSITY. IT WAS REPORTED THAT THE BALLOON BURST LONGITUDINALLY AT 6-8 ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. AFTER THE BALLOON RUPTURED THE PHYSICIAN HAD DIFFICULTY REMOVING IT. IN THE PROCESS THE CATHETER BROKE APART LEAVING A PORTION IN THE PATIENT/SHEATH. IT APPEARED TO BE IN MULTIPLE PIECES. THE BALLOON WAS STILL ON THE WIRE AND A 10MM GOOSENECK SNARE WAS ADVANCED FROM THE LEFT SIDE TO SNARE THE WIRE TO KEEP THE PARTS F

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

  MAUDE report 7220922 ↗

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