EverCross™ AB35W06020135 (UDI 00821684061572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061572), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2018Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A 6 X 20 EVERCROSS DEVICE TO TREAT A SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). SEVERE TORTUOSITY WAS REPORTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. PHYSICIAN USED A 6F NON -MEDTRONIC SHEATH ALONG WITH A NON-MEDTRONIC GUIDEWIRE. THE PHYSICIAN PRE-DILATED THE RIGHT COMMON FEMORAL AND PROXIMAL RIGHT SFA WITH A 3 X 100 NANOCROSS FOLLOWED BY A 4 X 100 NANOCROSS. A HAWKONE M WAS USED THROUGHOUT THE RIGHT COMMON FEMORAL AND RIGHT PROXIMAL SFA. THE IFU WAS FOLLOWED AND THE 6 X 20 EVERCROSS DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THE BALLOON RUPTURED AT 6ATM. THE PHYSICIAN UPSIZED TO A 7F NON-MEDTRONIC SHEATH TO REMOVE THE RUPTURED BALLOON. THE BALLOON WAS REMOVED AND REPLACED WITH A 5 X 200 EVERCROSS BALLOON IN THE PROXIMAL SFA. A 7 X 150 EVERFLEX STENT WAS PLACED IN THE PROXIMAL SFA. A 6 X 200 EVERCROSS BALLOON WAS USED AS POST DILATION OF THE RIGHT PROXIMAL SFA. WHEN REMOVING THE 6 X 200 EVERCROSS THE BALLOON RIPPED OFF AND WAS STUCK IN THE PROXIMAL SFA. THE PHYSICIAN TRIED USING A GOOSENECK SNARE DEVICE BUT UPSIZING THE SHEATH FROM THE 6F TO THE 7F ALLOWED REMOVAL OF THE BALLOON. WHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045949 ↗

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