EverCross™ AB35W05200135 (UDI 00643169973794)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169973794), received between Apr 7, 2021 and Apr 23, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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.

• InjuryApr 23, 2024Deflation Problem; Deflation Problem

  PHYSICIAN INTENDED TO USE AN EVERCROSS 035 PTA BALLOON WITH A 6X45 NON-MEDTRONIC SHEATH AND AN .035 NON-MEDTRONIC GUIDEWIRE DURING T REATMENT OF A 200MM PLAQUE LESION IN THE PATIENT'S LEFT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY WAS REPORTED. LESION EXHIBITED 50% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A 3MM BALLOON WITH NO COMPLICATIONS. THE VESSEL WAS NOT POST-DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. WHEN THE PHYSICIAN TRIED TO DEFLATE THE EVERCROSS BALLOON, IT WOULD NOT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163881 ↗
• MalfunctionApr 7, 2021Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. A SYRINGE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BURST/LEAK/RUPTURE ON THE CATHETER WAS REPORTED AS 10ATM ON FIRST INFLATION. DURING THE INFLATION IT WAS NOTED THE PRESSURE IN THE INFLATION SYRINGE BEGAN TO DROP SLOWLY BUT THE BALLOON WAS STILL INFLATED. UPON DEFLATION THERE WAS A SMALL AMOUNT OF BLOOD RETURN INSIDE THE SYRINGE. THE BALLOON WAS PLACED ON THE BACK TABLE AND INFLATED. DURING INFLATION A LEAK WAS NOTICE IN THE CATHETER JUST BEFORE THE PROXIMAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH PTA BALLOON ANGIOPLASTY AND DCB. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626680 ↗