EverCross™ AB35W12060080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684062333), received between Nov 17, 2017 and Mar 5, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS 035 BALLOON IN A FISTULOGRAM PROCEDURE IN THE BRACHIAL VEINS DESCRIBED AS APPROX. 30-40% STENOSIS. 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 WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC 7F SHEATH AND A 0.035 NON-MEDTRONIC WIRE PLATFORM WAS USED. THE DEVICE WAS INFLATED ONCE TO NOMINAL PRESSURE WITH HEP SALINE USED AS INFLATION FLUID. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE EVERCROSS 035 BALLOON RUPTURED DURING THE FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ANOTHER MEDTRONIC BALLOON OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8389433 ↗
• MalfunctionJan 31, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE AN EVERCROSS DEVICE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT NOMINAL PRESSURE WHILE USING AN INFLATION DEVICE WITH HEP AND SALINE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS REMOVED AND TWO MORE EVERCROSS DEVICES WERE USED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED WITH BOTH OF THESE DEVICES DURING INFLATION AT NOMINAL PRESSURE AND BOTH BALLOONS REMOVED FROM THE PATIENT. A FOURTH EVERCROSS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292234 ↗
• MalfunctionJan 31, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE AN EVERCROSS DEVICE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT NOMINAL PRESSURE WHILE USING AN INFLATION DEVICE WITH HEP AND SALINE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS REMOVED AND TWO MORE EVERCROSS DEVICES WERE USED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED WITH BOTH OF THESE DEVICES DURING INFLATION AT NOMINAL PRESSURE AND BOTH BALLOONS REMOVED FROM THE PATIENT. A FOURTH EVERCROSS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292224 ↗
• MalfunctionNov 17, 2017Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH AN 8 FR SHEATH FOR THE TREATMENT OF A FIBROUS LESION IN THE COMMON ILIAC VEIN. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT NOMINAL PRESSURE. IT WAS REPORTED THAT THE DEVICE PASSED THROUGH A NON-MEDTRONIC PREVIOUSLY DEPLOYED STENT, BUT NO RESISTANCE WAS ENCOUNTERED. THE BALLOON FRAGMENTS WERE RETRIEVED USING A 3-LOOP SNARE AND PHYSICIAN THEN USED NON-MEDTRONIC HIGH PRESSURE BALLOONS TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043356 ↗

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