EverCross™ AB35W05080135 (UDI 00763000184209)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000184209), received between Oct 1, 2020 and Feb 19, 2025 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 19, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS PTA BALLOON CATHETER, THERE WERE DEFLATION DIFFICULTIES. THE BALLOON TOOK 10 MINUTES TO FULLY DEFLATE FOR REMOVAL FROM THE POPLITEAL ARTERY. THE LESION WAS LOCATED IN THE MID-SECTION OF THE PERIPHERAL ARTERY WITH A LENGTH OF 60MM AND A DIAMETER OF 5MM, WITH MINIMAL TORTUOSITY AND CALCIFICATION. THE VESSEL WAS POST-DILATED, AND THE BALLOON WAS INFLATED USING A 50/50 CONTRAST FLUID. NEGATIVE PRESSURE WAS APPLIED TO FULLY DEFLATE THE BALLOON, AND AFTER SUFFICIENT TIME, THE DEVICE WAS SUCCESSFULLY WITHDRAWN THROUGH THE SHEATH. NO ISSUES WERE NOTED DURING INFLATION AND NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW EVERCROSS 5X100 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411421 ↗
• MalfunctionOct 1, 2020Burst Container or Vessel; Positioning Problem; Burst Container or Vessel; Positioning Problem

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S DISTAL COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. VESSEL DIAMETER IS REPORTED AS 6MM. LESION EXHIBITED 70% STENOSIS. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. 3 EVERCROSS PTA BALLOONS ARE REPORTED TO HAVE BEEN USED. NO DAMAGE WAS NOTED TO THE PACKAGING OF ANY OF THE DEVICES, AND NO ISSUES WERE NOTED DURING REMOVAL FROM THE PRODUCT PACKAGING. IFU WAS FOLLOWED AND THE 3 BALLOONS WERE PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE IS REPORTED TO HAVE BEEN USED FOR BALLOON INFLATION. EMBOLIC PROTECTION WAS NOT USED DURING THE PROCEDURE. FOR THE FIRST EVERCROSS BALLOON, IT IS REPORTED THAT NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A CIRCUMFERENTIAL/RADIAL BALLOON BURST IS REPORTED DURING BALLOON INFLATION AT A PRESSURE OF 15ATM (ABOVE RBP). 4 PRIOR INFLATIONS HAD BEEN APPLIED TO THE DEVICE. THE DEVICE WAS REPLACED. FOR THE SECOND EVERCROSS PTA BALLOON, IT IS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSL

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10611676 ↗
• MalfunctionOct 1, 2020Burst Container or Vessel; Positioning Problem; Burst Container or Vessel; Positioning Problem

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S DISTAL COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. VESSEL DIAMETER IS REPORTED AS 6MM. LESION EXHIBITED 70% STENOSIS. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. 3 EVERCROSS PTA BALLOONS ARE REPORTED TO HAVE BEEN USED. NO DAMAGE WAS NOTED TO THE PACKAGING OF ANY OF THE DEVICES, AND NO ISSUES WERE NOTED DURING REMOVAL FROM THE PRODUCT PACKAGING. IFU WAS FOLLOWED AND THE 3 BALLOONS WERE PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE IS REPORTED TO HAVE BEEN USED FOR BALLOON INFLATION. EMBOLIC PROTECTION WAS NOT USED DURING THE PROCEDURE. FOR THE FIRST EVERCROSS BALLOON, IT IS REPORTED THAT NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A CIRCUMFERENTIAL/RADIAL BALLOON BURST IS REPORTED DURING BALLOON INFLATION AT A PRESSURE OF 15ATM (ABOVE RBP). 4 PRIOR INFLATIONS HAD BEEN APPLIED TO THE DEVICE. THE DEVICE WAS REPLACED. FOR THE SECOND EVERCROSS PTA BALLOON, IT IS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSL

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10611667 ↗