EverCross™ AB35W06120135 (UDI 00821684061725)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684061725), received between May 18, 2017 and Jan 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT LESION IN PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. A NON MEDTRONIC 6 FR SHEATH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 5 ATM. THIS WAS REPORTED FOR TWO BALLOONS. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222849 ↗
• MalfunctionJul 11, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON CATHETER TO TREAT A UNKNOWN LESION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON RUPTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705038 ↗
• MalfunctionMay 18, 2017Material Rupture

  DURING PROCEDURE, BALLOON ON DEVICE RUPTURED.

  Patient problems: No Information

  MAUDE report 6581400 ↗

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