EverCross™ AB35W06030135 (UDI 00821684061596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061596), received between Apr 3, 2018 and Nov 21, 2019 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionNov 21, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR SHEATH DURING TREATMENT OF A 30MM SOFT TISSUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6-7MM. NO VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. LESION EXHIBITED 60-70% STENOSIS. IFU WAS FOLLOWED. NO ISSUES NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING DEVICE FROM PACKAGING. DEVICE PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THAT BALLOON INFLATION DIFFICULTIES WERE EXPERIENCED AT A PRESSURE OF 6ATM. THE DEVICE WAS REMOVED SAFELY FROM THE PATIENT, AN INFLATION WAS PERFORMED AND A LEAK WAS IDENTIFIED COMING FROM THE DISTAL TIP OF THE CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER EVERCROSS TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9352782 ↗
• InjuryApr 3, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN USED AN EVERCROSS DEVICE DURING TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS REPORTED TO EXHIBIT 90% STENOSIS AND THE VESSEL WAS REPORTED TO EXHIBIT NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. A NON-MDT INFLATION DEVICE WAS USED. IT IS REPORTED THAT A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 8ATMS ON THE SECOND INFLATION. THERE WERE NO BALLOON FRAGMENTS. A 6X40 EVERFLEX STENT WAS THEN DEPLOYED TO COVER THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7391422 ↗

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