EverCross™ AB35W05040135 (UDI 00821684061398)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684061398), received between May 17, 2018 and Feb 11, 2020 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2020Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER ALONG WITH NON MEDTRONIC 6FR SHEATH AND .035" GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 40MM RESPECTIVELY. A NON MEDTRONIC BALLOON INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WERE NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT DURING DELIVERY THROUGH THE VESSEL THE BALLOON BURST AT 4ATM. ANOTHER SHEATH WAS INSERTED IN OPPOSITE SIDE AND DEVICES WERE CAPTURED OVER THE WIRE THROUGH THE OPPOSITE SHEATH. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9695061 ↗
• InjuryMar 27, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE AN EVERCROSS BALLOON HAD BEEN USED IN RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). WHEN ATTEMPTING TO WITHDRAW THE BALLOON IT APPEARED TO SHEAR OFF WHEN CROSSING STENTS IN THE RIGHT COMMON ILIAC ARTERY. MULTIPLE MANOEUVRES WERE TRIED TO REMOVE THE PORTION OF THE BALLOON THAT HAD SHEARED OFF HOWEVER, THE DISTAL MARKER COULD BE STILL SEEN IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO TRAP THE BROKEN BALLOON WITH A STENT. A WIRE WAS NEGOTIATED PAST THE AREA AND AN 8X37 BALLOON EXPANDABLE STENT WAS DEPLOYED ONCE ADVANCED TO THE APPROPRIATE AREA. GOOD BLOOD FLOW WAS OBSERVED WITH NO EVIDENCE OF FOREIGN MATERIAL IN THE RIGHT LOWER EXTREMITY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8456230 ↗
• MalfunctionMay 17, 2018Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS BALLOON WITH A NON-MDT INFLATION DEVICE. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE EXPERIENCED FOLLOWING THE FIRST INFLATION. THE BALLOON WAS ABLE TO BE REMOVED FROM THE SHEATH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521363 ↗

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