EverCross™ AB35W06150135 (UDI 00821684061749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061749), received between Sep 21, 2017 and Dec 12, 2018 — classified as 2 malfunctions.

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.

• MalfunctionDec 12, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN ATTEMPTED TO USE AN EVERCROSS BALLOON WITH A NON-MEDTRONIC 6 F SHEATH AND GUIDEWIRE TO TREAT A MODERATELY CALCIFIED 150MM LESION WITH 40% STENOSIS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL PRESENTED MINIMAL TORTUOSITY. THE ARTERY DIAMETER WAS 6MM. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES. AN INFLATION DEVICE WAS USED. IT WAS REPORTED THAT A LONGITUDINAL BURST OCCURRED DURING INFLATION OF THE BALLOON AT 10 ATM. THE BALLOON WAS RETRIEVED SUCCESSFULLY FROM PATIENT AND THE PROCEDURE WAS COMPLETED USING A CHOCOLATE BALLOON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8154820 ↗
• MalfunctionSep 21, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT MID COMMON ILIAC ARTERY. THE LESION HAD CHRONIC TOTAL OCCLUSION (CTO) AND WAS 150 MM IN LENGTH. THE ARTERY DIAMETER IS 6-7 MM WITH LITTLE TORTUOSITY. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AS PER THE IFU. A NON-MEDTRONIC GUIDEWIRE WAS USED WITH A NON-MEDTRONIC 5 FR SHEATH WITH NO EMBOLIC PROTECTION. THE BALLOON WAS INFLATED USING NON-MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST/ SALINE MIX INFLATION FLUID. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THERE WAS NO RESISTANCE WHEN THE BALLOON WAS ADVANCED, AND NO ISSUES WERE NOTED DURING INFLATION. IT WAS REPORTED THAT THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE (APPROX 10 SECONDS). INITIALLY, THE TECHNICIAN DEFLATED THE BALLOON AND THE ANGIOGRAPH REVEALED IT WAS NOT FULLY DEFLATED. NEGATIVE PRESSURE WAS APPLIED AND IT WAS AGAIN SHOWN ON THE ANGIOGRAPH THE BALLOON WAS NOT COMPLETELY DEFLATED. THE BALLOON WAS INITIALLY INFLATED AT 12 ATM FOR 180 SECS, THE BALLOON WAS THEN REPOSITIONED SLIGHTLY FOR SECOND INFLATION AT 10 ATM FOR 180 SECS. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885159 ↗

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