EverCross™ AB35W04200135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061305), received between Apr 17, 2018 and Apr 24, 2019 — classified as 2 malfunctions.

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.

• MalfunctionApr 24, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS USING AN EVERCROSS BALLOON TO TREAT A CALCIFIED PLAQUE LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). LITTLE TORTUOSITY WAS REPORTED BUT NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT A PIN HOLE BALLOON BURST OCCURRED DURING INFLATION TO 8ATM USING A SYRINGE. ALL FRAGMENTS OF THE BALLOON WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543525 ↗
• MalfunctionApr 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON TO TREAT A LESION IN A RIGHT LEG FEM-POP BYPASS GRAFT (SFA TO PT). THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED AND FLUSHED PER THE IFU. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE BALLOON WAS SUCCESSFULLY DELIVERED OVER A NON-MDT GUIDEWIRE TO THE LESION SITE. AS THE PHYSICIAN STARTED TO INFLATE THE BALLOON WITH A NON-MDT INFLATION DEVICE TO AN UNKNOWN PRESSURE, CONTRAST WAS NOTICED FLOWING PAST THE BALLOON AND INTO THE VESSEL. NO BALLOON EXPANSION OCCURRED. THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND INFLATED ON THE TABLE - AGAIN, CONTRAST LEAKED FROM THE BALLOON. THE PHYSICIAN USED A NEW BALLOON TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THE PATIENT WAS TREATED WITH A TISSUE PLASMINOGEN ACTIVATOR(TPA) DRIP OVERNIGHT. THE PHYSICIAN REPORTED THAT THE PATIENT PRESENTED WITH A CLOT INITIALLY. THERE WAS NEVER ANY RISK TO THE PATIENT REPORTED DURING THIS PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7435541 ↗

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