EverCross™ AB35W07040080 (UDI 00821684061831)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061831), received between Aug 8, 2018 and Nov 6, 2018 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 7X40 EVERCROSS BALLOON TO TREAT A MODERATELY CALCIFIED SOFT TISSUE LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 8 ATM. IT WAS REPORTED THAT THE PHYSICIAN THEN ATTEMPTED TO USE A 7X60 EVERCROSS BALLOON. IT WAS REPORTED THAT THE EVERCROSS BALLOON BURST DURING INFLATION AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER EVERCROSS 7X60. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042654 ↗
• InjuryAug 8, 2018Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON DILATION CATHETER TO TREAT AN AV FISTULA CLOT IN THE RIGHT ARM. THE DEVICE WAS REPORTED TO HAVE BEEN PREPPED AS PER IFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR TO THE DEVICE UPON REMOVAL FROM THE TRAY. NO EMBOLIC PROTECTION WAS USED. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE VESSEL DIAMETER WAS REPORTED TO BE 7MM. POST BALLOON INFLATION DIFFICULTIES WERE EXPERIENCED DURING REMOVAL. THE BALLOON CATHETER AND TIP WERE REPORTED TO HAVE DETACHED AT THE CATHETER SHAFT INSIDE THE BALLOON. THESE WERE SNARED AND REMOVED, USING 2 X GOOSENECK SNARES - A 10MM LOOP AND A 25MM LOOP. HOWEVER, A PORTION OF THE BALLOON REMAINED IN THE PATIENT & IT WAS REPORTED THAT THE FISTULA FLOW WAS NOT FULLY RESTORED. THE DECISION WAS THEN MADE TO HOLD PRESSURE AND OCCLUDE THE FISTULA COMPLETELY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7761257 ↗

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