Skip to content

EverCross™ AB35W12040080Recalls & reported problems

Ev3, Inc · PTA AB35W12040080 EVERCROSS 035 V05 · Class 2

All models of EverCross (114)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684062319), received between Sep 1, 2017 and Sep 1, 2017 — 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

Device problems

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjurySep 1, 2017Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

    PHYSICIAN USED AN EVERCOSS PTA BALLOON WITH A 7FR SHEATH AND AN UNKNOWN GUIDEWIRE FOR THE TREATMENT OF AN UNKNOWN LESION TYPE IN THE ILIAC VEIN (DIAMETER 12MM). EMBOLIC PROTECTION WAS NOT USED. THE IFU WAS FOLLOWED AND DEVICE WAS PREPPED WITHOUT ISSUE. THE BALLOON WAS INFLATED USING AN UNKNOWN INFLATION DEVICE WITH A CONTRAST/SALINE FLUID TO A PRESSURE OF 8 ATM. IT WAS REPORTED THAT A BREAK OCCURRED AT THE SHEATH DURING REMOVAL. THE DETACHED PORTION REMAINS IN THE PATIENT. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED OR IF EXCESSIVE FORCE WAS USED. IN ORDER TO COMPLETE THE PROCEDURE, THE REMAINING BALLOON FRAGMENT WAS STENTED OVER WITHIN THE VESSEL (UNKNOWN SIZE STENT USED). NO PATIENT INJURY REPORTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6840177 ↗

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

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page