EverCross™ AB35W06040135 (UDI 00821684061626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061626), received between May 2, 2019 and Jul 1, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS 6X40 PTA BALLOON TO TREAT A MODERATELY CALCIFIED NON TORTUOUS LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS DESCRIBED AS CALCIFIED AND APPROX. 95% STENOTIC. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 6MM 120MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH WAS USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND 50/50 SOLUTION WAS USED AS INFLATION FLUID. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE BALLOON WAS REPORTED TO HAVE RUPTURED INSIDE THE STENT. A 7X40 EVERCROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747796 ↗
• MalfunctionMay 2, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS USING AN EVERCROSS BALLOON TO TREAT A MODERATELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING INITIAL BALLOON INFLATION TO 10ATM, USING A MERIT INFLATION DEVICE WITH HEP/SALINE AND CONTRAST, THE BALLOON BURST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573654 ↗

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