EverCross™ AB35W06200135 (UDI 00821684061763)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684061763), received between Sep 17, 2018 and Jan 26, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 18, 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.

• MalfunctionJan 26, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A NON-MEDTRONIC INFLATION DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST IS REPORTED DURING INFLATION AT 6ATM. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. AN EVERCROSS OF A DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228613 ↗
• MalfunctionJun 24, 2019Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS DEVICE DURING TREATMENT OF A LESION DESCRIBED AS BEING CALCIFIED/ FIBROUS/ PLAQUE IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE LESION EXHIBITED 70% STENOSIS. IFU WAS FOLLOWED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE BALLOON WAS INFLATED TO A PRESSURE OF 11ATM IN A STENT IN THE PATIENT¿S SFA. THE BALLOON IS REPORTED TO HAVE BURST ON SECOND INFLATION. THE BALLOON WAS REMOVED OF THE PATIENT AND CLOSED THE COMMON FEMORAL ARTERY (CFA). NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725978 ↗
• InjuryNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A 6X20 EVERCROSS DEVICE TO TREAT A SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). SEVERE TORTUOSITY WAS REPORTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. PHYSICIAN USED A 6F NON -MEDTRONIC SHEATH ALONG WITH A NON-MEDTRONIC GUIDEWIRE. THE PHYSICIAN PRE-DILATED THE RIGHT COMMON FEMORAL AND PROXIMAL RIGHT SFA WITH A 3 X 100 NANOCROSS FOLLOWED BY A 4 X 100 NANOCROSS. A HAWKONE M WAS USED THROUGHOUT THE RIGHT COMMON FEMORAL AND RIGHT PROXIMAL SFA. THE IFU WAS FOLLOWED AND THE 6X20 EVERCROSS DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THE BALLOON RUPTURED AT 6ATM. THE PHYSICIAN UPSIZED TO A 7F NON-MEDTRONIC SHEATH TO REMOVE THE RUPTURED BALLOON. THE BALLOON WAS REMOVED AND REPLACED WITH A 5 X 200 EVERCROSS BALLOON IN THE PROXIMAL SFA. A 7 X 150 EVERFLEX STENT WAS PLACED IN THE PROXIMAL SFA. A 6 X 200 EVERCROSS BALLOON WAS USED AS POST DILATION OF THE RIGHT PROXIMAL SFA. WHEN REMOVING THE 6 X 200 EVERCROSS THE BALLOON RIPPED OFF AND WAS STUCK IN THE PROXIMAL SFA. THE PHYSICIAN TRIED USING A GOOSENECK SNARE DEVICE BUT UPSIZING THE SHEATH FROM THE 6F TO THE 7F ALLOWED REMOVAL OF THE BALLOON. WHEN RE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8045851 ↗
• MalfunctionSep 17, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A MODERATELY CALCIFIED LESION IN THE PATIENTS MID SUPERFICIAL FEMORAL ARTERY(SFA). NO TORTUOSITY WAS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A PINHOLE BURST OCCURRED AT AN INFLATION PRESSURE OF 4ATMS. IT IS UNKNOWN HOW MANY PRIOR INFLATIONS WERE APPLIED TO THE BALLOON. THE BALLOON WAS REMOVED WITHOUT ISSUE - WITH NO FRAGMENTS LEFT IN THE PATIENT. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881003 ↗

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