EverCross™ AB35W08060135 (UDI 00821684062081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684062081), received between Mar 8, 2019 and Mar 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryMar 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON TO TREAT A LESION IN THE MID ILIAC ARTERY ¿ COMMON WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION 60% STENOSIS IN A PATIENT. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DEVICE OR COMPONENT DETACHED, CRACKED, OR FRACTURED DURING DELIVERY THROUGH THE VESSEL AT THE BALLOON. A DETACHED PORTIONED OF THE BALLOON REMAINED IN THE PATIENT WHICH WAS STENTED IN PLACE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8403089 ↗

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