EverCross™ AB35W04120135 (UDI 00821684061268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061268), received between Jul 29, 2021 and Jul 29, 2021 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. A NON-MEDTRONIC PRESSURE PUMP WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST IS REPORTED DURING THIRD INFLATION OF THE DEVICE AT 18ATM. TWO PRIOR INFLATIONS HAD BEEN APPLIED TO THE DEVICE, FIRST INFLATION TO 10ATM, AND SECOND INFLATION TO 18ATM. THE DEVICE WAS REPLACED WITH ANOTHER EVERCROSS OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12244994 ↗

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