EverCross™ AB35W08040135 (UDI 00821684062050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684062050), received between Aug 14, 2018 and Feb 27, 2020 — classified as 1 injury, 1 malfunction.

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.

• InjuryFeb 27, 2020Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED AN EVERCROSS PTA BALLOON OVER A NON-MEDTRONIC WIRE DURING TREATMENT OF THE PATIENT¿S LEFT ILIAC ARTERY. ACCESS WAS FROM THE LEFT UPPER LIMB. INFLATION WAS PERFORMED BELOW RBP TO A MAXIMUM OF 13 ATM. DURING BALLOON INFLATION, THE BALLOON IS REPORTED TO HAVE BURST. DURING REMOVAL OF THE BALLOON WHEN IT REACHED THE END OF THE SHEATH IT SNAPPED, RESULTING IN APPROXIMATELY 80% OF THE BALLOON REMAINING TRAPPED IN THE ARTERY. UNSUCCESSFUL ATTEMPTS WERE MADE WITH A SNARE TO REMOVE THE DETACHED PORTION. THE PROCEDURE WAS ABANDONED, AND THE PATIENT WAS TAKEN TO VASCULAR THEATRE FOR SURGICAL REMOVAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9762531 ↗
• MalfunctionAug 14, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON DILATION CATHETER TO TREAT A MODERATELY CALCIFIED MID RIGHT COMMON ILIAC ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND THE LESION HAD RESULTED IN 90% STENOSIS. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED ADVANCING THE DEVICE AND IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING THE FIRST BALLOON INFLATION AT 7ATM THE BALLOON BURST. THE PROCEDURE USED A NON-MDT INFLATION DEVICE. THERE WERE NO BALLOON FRAGMENTS. ALL OF DEVICE WAS WITHDRAWN FROM THE PATIENT WITHOUT INTERVENTION. THE ARTERY WAS STENTED WITH A 10X40 PROTEGE, AND POST DILATED WITH A COMPETITIVE BALLOON TO COMPLETE THE PROCEDURE. THE USE OF THE PROTEGE WAS PLANNED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780070 ↗

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