EverCross™ AB35W05100135 (UDI 00821684061473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684061473), received between Jun 20, 2018 and Jul 31, 2019 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON TO TREAT A MODERATELY CALCIFIED, SLIGHTLY TORTUOUS, CALCIFIED 50% STENOTIC LESION IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITH NO ISSUE IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS INFLATED WITH A SYRINGE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, HOWEVER, RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION TO 7ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845053 ↗
• InjuryJul 30, 2018Burst Container or Vessel; Material Rupture; Physical Resistance/Sticking; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT BILATERAL COMMON ILIAC LESIONS. NO EMBOLIC PROTECTION WAS USED. RIGHT COMMON FEMORAL ACCESS WAS ATTEMPTED TO PLACE A NON-MDT 6 FR 90CM SHEATH UP AND OVER THE AORTIC BIFURCATION ON .035¿ NON-MDT GUIDEWIRE. THE PATIENT HAD SIGNIFICANT BILATERAL COMMON ILIAC DISEASE AND RESISTANCE WAS MET TRYING TO ADVANCE THE SHEATH. ATTEMPTS WERE MADE TO DILATE THE ILIACS WITH A 5MMX60MM NON-MDT BALLOON USING A NON-MEDTRONIC INFLATION DEVICE AND SALINE/CONTRAST MIXTURE. THIS BALLOON RUPTURED PRIOR TO MAXIMUM DILATION. THE PHYSICIAN THEN PREPARED A 5MMX100MM EVERCROSS BALLOON AS PER IFU AND ATTEMPTED TO PLACE IT ACROSS BOTH COMMON ILIACS. THIS DEVICE WAS INFLATED TO 18ATMS HOWEVER, IT RUPTURED IN THE SEVERELY CALCIFIED RIGHT PROXIMAL COMMON ILIAC ARTERY LESION. THE ARTERY HAD LITTLE TORTUOSITY AND WAS 12MM IN DIAMETER. THE LESION HAD RESULTED IN 75% STENOSIS. RESISTANCE WAS MET WHEN REMOVING THIS BALLOON AND WHEN REMOVED FROM THE SHEATH IT WAS NOTICED THAT THERE WAS BALLOON MATERIAL MISSING FROM THE BALLOON CATHETER. AT THIS POINT THE .035 WIRE WAS EXCHANGED FOR AN .014¿ X300CM NITREX WIRE AND AN INTRAVASCULAR ULTRASOUND(IVUS) CATHETER WAS US

  Patient problems: Patient Problem/Medical Problem; Stenosis

  MAUDE report 7731081 ↗
• MalfunctionJun 20, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED AN EVERCROSS BALLOON WITH A 6FR NON-MDT SHEATH AND 0.035" NON-MDT GUIDEWIRE FOR TREATMENT OF A 100MM CTO (CHRONIC TOTAL OCCLUSION-100%) CALCIFIED LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA) OF DIAMETER 6MM. THE VESSEL WAS REPORTED TO BE SLIGHTLY TORTUOUS. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MDT INFLATION DEVICE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO EXCESSIVE FORCE WAS USED AND THERE WAS NO RESISTANCE ENCOUNTERED. IT WAS REPORTED THAT, FOLLOWING THE FIRST INFLATION, DEFLATION ISSUES WERE NOTED. THE PHYSICIAN PULLED NEGATIVE SEVERAL TIMES ON THE INFLATION DEVICE TRIED A NEW ONE WITH NO SUCCESS. THE PHYSICIAN ALSO ATTEMPTED PULLING NEGATIVE WITH A 20CC SYRINGE WITHOUT SUCCESS. THE BALLOON EVENTUALLY DEFLATED ENOUGH AFTER MORE THAN 5 MINS SO THAT THE PHYSICIAN WAS ABLE TO PULL IT INTO THE SHEATH. THIS SLOWLY DEFLATED THE BALLOON SUFFICIENTLY TO BE ABLE TO REMOVE IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7618635 ↗

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