EverCross™ AB35W04080135 (UDI 00821684061220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061220), received between Apr 26, 2019 and Apr 26, 2019 — 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.

• MalfunctionApr 26, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN EVERCROSS 4X80 BALLOON TO TREAT A CALCIFIED 50% STENOTIC LESION IN THE MID POPLITEAL ARTERY. TORTUOUSITY AND CALCIFICATION WERE DESCRIBED AS SEVERE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED, NOR EXCESSIVE FORCE APPLIED, DURING DELIVERY OF THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE BALLOON BURST AT 6ATM. THE BURST WAS DESCRIBED AS A PIN HOLE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 4X80 EVERCROSS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8554462 ↗

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