EverCross™ AB35W05040080 (UDI 00821684061381)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684061381), received between Jul 27, 2017 and Nov 21, 2018 — classified as 1 death, 1 injury.

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. 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.

• InjuryNov 21, 2018Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS BALLOON DURING TREATMENT OF THE PATIENT¿S LEFT SUBCLAVIAN VEIN. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NON-MEDTRONIC WIRES 5FR 10 CM SHEATH AND INFLATION DEVICE WERE USED. IT IS REPORTED THAT THE BALLOON RUPTURED FOLLOWING FIRST INFLATION. THE BALLOON WAS INFLATED TO RATED BURST PRESSURE (RBP). WHEN THE BURST OCCURRED, THE BALLOON BROKE OFF THE CATHETER AND WAS UNABLE TO BE REMOVED FROM THE PATIENT. EXCESSIVE FORCE WAS USED WHEN TRYING TO WITHDRAW THE BALLOON. IT IS BELIEVED THAT THE BALLOON REMAINED ATTACHED TO THE CATHETER FOLLOWING THE BURST UNTIL IT REACHED A MORE PROXIMAL STENOSIS IN WHICH EXCESSIVE FORCE WAS USED IN ATTEMPT TO CROSS THIS LESION. IT APPEARS THAT THIS PROXIMAL LESION IS WHERE THE BALLOON CAME APART FROM THE CATHETER. PATIENT WAS TAKEN TO SURGERY TO REMOVE THE BALLOON. NO ATTEMPTS AT SNARING THE BALLOON WERE MADE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8096072 ↗
• DeathJul 27, 2017Difficult to Remove; Difficult to Remove

  PHYSICIAN USED AN EVERCROSS PTA BALLOON WITH A 6 F SHEATH AND.035 GUIDEWIRE FOR THE TREATMENT OF A MODERATELY TORTUOUS, SEVERELY CALCIFIED 40MM LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY OF DIAMETER 6MM WHICH EXHIBITED CTO (CHRONIC TOTAL OCCLUSION). EMBOLIC PROTECTION WAS NOT USED. THE DEVICE IFU WAS FOLLOWED AND NO ISSUES NOTED DURING PREP. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE (INFLATION FLUID UNKNOWN) TO A PRESSURE OF 10ATMS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED SENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT AFTER INFLATION, THE BALLOON BECAME STUCK IN THE PATIENT¿S LEG. WHEN PHYSICIAN TRIED TO RETRIEVE IT, THE PATIENT DEVELOPED A LEAK AT THE BASE OF HER AORTA (BALLOON WAS FULLY DEFLATED FOR REMOVAL). PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR FEMORAL ENDARTERECTOMY FOLLOWING SEVERAL ATTEMPTS AT REMOVING THE BALLOON. THE PATIENT DIED DAYS LATER AFTER THE PROCEDURE IN THE ICU. PHYSICIAN REPORTED THE CAUSE OF DEATH IS SEVERE PERIPHERAL VASCULAR DISEASE (PVD).

  Patient problems: Death

  MAUDE report 6749437 ↗

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