EverCross™ AB35W05080135 (UDI 00821684061459)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061459), received between May 9, 2017 and May 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionMay 9, 2017Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  AN EVERCROSS PTA BALLOON CATHETER WAS PREPPED AS PER IFU WITH NO ISSUES NOTED FOR THE TREATMENT OF A SOFT TISSUE LESION WITH LITTLE TORTUOSITY, AND CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY. % OF LESION STENOSIS UNKNOWN. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED WITH A SYRINGE USING CONTRAST INFLATION FLUID. BALLOON WAS SLIGHTLY RESISTANT TO INFLATION WHICH WAS NOTICED WHEN A PRESSURE OF 10 ATM WAS APPLIED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. WHEN THE PHYSICIAN TRIED TO DEFLATE THE BALLOON, IT WOULD NOT DEFLATE AT THE LESION SITE, THEREFORE MAKING REMOVAL DIFFICULT. PHYSICIAN REMOVED 1-2 DROPS OF CONTRAST FROM THE DEVICE USING A 60 ML SYRINGE. THE BALLOON WAS INCOMPLETELY DEFLATED BUT WAS PULLED BACK THROUGH THE VESSEL. WHEN IT WAS FORCIBLY PULLED BACK INTO THE SHEATH THE BALLOON EVENTUALLY EMPTIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6554296 ↗

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