EverCross™ AB35W06040080 (UDI 00763000184360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184360), received between Nov 15, 2019 and Dec 17, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• InjuryDec 17, 2021Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE PROXIMAL RIGHT FISTULA VEIN GRAFT-10+ YEARS OLD. THE VESSEL HAD MODERATE TORTUOSITY AND EXHIBITED 90% STENOSIS. THE ANATOMY WAS EXTREMELY CALCIFIED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. IT WAS REPORTED THAT THERE WAS A CIRCUMFERENTIAL/RADIAL BALLOON BURST AT 8ATMS ON FIRST INFLATION. NOT ALL FRAGMENTS WERE RETRIEVED. THERE WERE REMOVAL DIFFICULTIES REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. PORTION OF THE BALLOON WAS CAUGHT IN CALCIUM. UNABLE TO SNARE MATERIAL OUT OF VEIN GRAFT. A NON MEDTRONIC COVERED STENT WAS USED IN THE VEIN GRAFT TO TACK BALLOON MATERIAL BETWEEN THE WALL OF THE VEIN AND THE COVERED STENT. THIS WAS TO ENSURE THAT THE BALLOON THAT WAS NOT RETRIEVED WOULD NOT MIGRATE. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13024376 ↗
• MalfunctionAug 20, 2020Leak/Splash; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR 11CM SHEATH AND 0.035" GLIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID COMMON ILIAC ARTERY WITH 80% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 20MM RESPECTIVELY. NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. BALLOON BURST/LEAK/RUPTURE OCCURRED DURING FIRST BALLOON INFLATION AT 8ATM. ALL FRAGMENTS OF BALLOON WERE REMOVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHILE ADVANCING DEVICE. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED TO THE TARGET LESION. UPON THE FIRST INFLATION PHYSICIAN NOTICED CONTRAST DYE LEAKING FROM THE BALLOON INTO THE ARTERY. BALLOON WAS DEFLATED THE BALLOON AND REMOVED INTACT WITH NO HARM TO THE PATIENT. AN IDENTICAL BALLOON WAS USED TO COMPLETE THE PROCEDURE ACHIEVING AN EXCELLENT RESULT. THE PROCEDURE WAS COMPLETED USING AN IDENTICAL BALLOON, THIS BALLOON WAS USED WITH ZERO ISSUES. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429746 ↗
• InjuryNov 15, 2019Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking; Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR SHEATH AND 0.035 NON-MEDTRONIC WIRE DURING TREATMENT OF A FIBROUS LESION IN A PROXIMAL RIGHT UPPER ARM FISTULA GRAFT. VESSEL DIAMETER REPORTED AS 6MM. LESION EXHIBITED 90% STENOSIS. SLIGHT TORTUOSITY REPORTED. IFU WAS FOLLOWED. NO PACKAGING ISSUES NOTED PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. AN INFLATION DEVICE WAS USED WITH 1:3, CONTRAST: SALINE MIX FOR BALLOON INFLATION. IT IS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED DURING FIRST INFLATION AT PRESSURE OF 14ATM. THE BALLOON REMAINED ON THE WIRE. THE SHEATH WAS UPSIZED TO 9FR AND A SNARE WAS ADVANCED DOWN BESIDE EXISTING WIRE AND SNARE END OF WIRE AND PULL EVERYTHING OUT TOGETHER. IT IS BELIEVED THAT THE STAPLES FROM PLACEMENT OF SYNTHETIC GRAFT MAY HAVE BEEN WHAT RUPTURED THE BALLOON. SLIGHT RESISTANCE WAS FELT WHILE TRYING TO REMOVE BALLOON AFTER RUPTURE. GENTLE PRESSURE WAS APPLIED AS RESISTANCE IS EXPECTED WITH A RUPTURED BALLOON. ON

  Patient problems: Rupture

  MAUDE report 9327539 ↗