EverCross™ AB35W06040080 (UDI 00821684061619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684061619), received between Aug 1, 2017 and Oct 16, 2018 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS WITH A 7FR SHEATH TO TREAT THE SUPERFICIAL FEMORAL ARTERY. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT DURING REMOVAL OF THE BALLOON THROUGH THE SHEATH IT RUPTURED AND THE END PIECE CAME OFF. THE BROKEN PORTION REMAINED IN THE SHEATH THUS ALLOWING IT TO BE RETRIEVED BY PULLING OUT THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE AND NO PARTS REMAINED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969855 ↗
• MalfunctionDec 8, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO TREAT A LESION USING AN EVERCROSS PTA BALLOON. THE PROCEDURE USED A NON-MEDTRONIC GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED DURING THE ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT PHYSICIAN WAS UNABLE TO REMOVE THE BALLOON DEVICE FROM THE GUIDEWIRE. THE GUIDEWIRE GOT STUCK IN THE TIP OF THE BALLOON. THE PHYSICIAN WAS ABLE TO PULL EVERYTHING OUT THROUGH THE SHEATH. NO INTERVENTIONS WERE REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101498 ↗
• InjuryOct 5, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER IN A PATIENT WHEN THE BALLOON BURST. THE BALLOON WAS REMOVED FROM THE PATIENT BUT A PORTION OF THE BALLOON REMAINED IN THE PATIENT. A STENT WAS DEPLOYED TO JAIL THE BALLOON FRAGMENT AGAINST THE WALL OF THE ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 6915750 ↗
• InjuryAug 1, 2017Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS PTA BALLOON DEVICE FOR A FISTULOPLASTY PROCEDURE OF THE ARM. IFU WAS FOLLOWED. AN INFLATION DEVICE WAS USED FOR INFLATION. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT A PRESSURE OF 11ATMS. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO REMOVE THE BALLOON, AND IT SHEARED OFF ON SHEATH AND SNAPPED. THE BALLOON REMAINED IN THE VESSEL. PHYSICIAN HAD TO PERFORM A CUT DOWN TO RETRIEVE THE BALLOON FRAGMENTS. IT WAS REPORTED THAT VESSEL INJURY OCCURRED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6758714 ↗

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