EverCross™ AB35W08060080 (UDI 00821684062074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684062074), received between Apr 3, 2019 and Jul 21, 2021 — classified as 2 injuries.

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.

• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A EVERCROSS BALLOON WAS USED TO TREAT THE SWING POINT OF THE LEFT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED OCCLUSIVE THROMBUS IN THE BASILIC VEIN, OBSTRUCTION PROXIMAL TO AV ANASTOMOSIS AND MID PROXIMAL SWING SEGMENT BASILIC VEIN STENOSIS AND DILATION. THE EVENT WAS TREATED WITH THROMBECTOMY, PTA AND STENTING OF TARGET LESION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12201426 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A FORMER SMOKER WITH A MEDICAL HISTORY OF HYPERTENSION, DIABETES, RENAL INSUFFICIENCY AND CAROTID ARTERY DISEASE. DURING THE INDEX PROCEDURE ONE EVERCROSS 8MMX60MM BALLOON WAS USED WITH AN INPACT ADMIRAL DCB TO TREAT THE SWING POINT OF THE LEFT ARM ((B)(6) 2017). APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED FROM EXCESSIVE BLEEDING FROM FISTULA POST DIALYSIS ((B)(6) 2018). THE EVENT WAS DESCRIBED AS AVF STENOSIS AND REPAIR. FISTULOGRAM CORRECTED THE ISSUE. A FISTULOGRAM WAS PERFORMED AND THE SWING POINT WAS TREATED WITH A NON-MDT PTA. THE PATIENT RECOVERED. APPROXIMATELY 6 MONTHS POST PROCEDURE ((B)(6) 2018), PATIENT SUFFERED LEFT AVF BLEEDING AND WAS TREATED WITH COUMADIN, TWO SUTURES, SURGICAL INTERVENTION AND REVASCULARIZATION OF THE SWING POINT WITH NON-MEDTRONIC PTA ((B)(6) 2018). APPROXIMATELY 11 MONTHS POST PROCEDURE ((B)(6) 2018), PATIENT SUFFERED MALFUNCTION OF THE LEFT UPPER EXTREMITY FISTULA, THE PATIENT WAS TREATED WITH REVASCULARIZATION OF THE VENOUS OUTFLOW WITH NON-MEDTRONIC PTA ((B)(6) 2018).

  Patient problems: Fistula; Patient Problem/Medical Problem; Stenosis

  MAUDE report 8477179 ↗

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