EverCross™ AB35W07060135 (UDI 00763000184629)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000184629), received between Apr 30, 2020 and Jan 3, 2024 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Difficult to Insert; Use of Device Problem; Difficult to Advance; Difficult to Insert; Use of Device Problem; Difficult to Advance

  AN EVERCROSS PTA BALLOON WAS INTENDED TO BE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE DEVICE COULD NOT ENTER THE LESION WITH THE GUIDEWIRE. IT WAS NOTED THAT THE DEVICE WAS USED ONE DAY POST EXPIRY. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434118 ↗
• MalfunctionSep 1, 2023Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS 035 PTA BALLOON DURING TREATMENT OF THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT IS REPORTED DURING THE LOWER EXTREMITY ARTERIAL OCCLUSION OPERATION, THE EVERCROSS PRODUCT LEAKED FLUID FROM THE BALLOON DURING BALLOON INFLATION AT 5 ATMS, WHICH MADE THE PRODUCT UNUSABLE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669166 ↗
• MalfunctionSep 8, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 45CM 7FR SHEATH AND A 7MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A CALCIFIED SOFT TISSUE LESION IN THE PATIENTS MID COMMON FEMORAL ARTERY (CFA). MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. AN UNKNOWN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED A BALLOON LEAK OCCURRED AT 10 ATM. TWO PRIOR INFLATIONS HAD BEEN APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. THERE WAS NO DAMAGE TO PREVIOUSLY DEPLOYED STENT. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO VESSEL INJURY. THE DEVICE WAS REPLACED WITH ANOTHER 7X80 PTA TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377112 ↗
• InjuryApr 30, 2020Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE AN EVERCROSS PTA BALLOON WITH AN 8FR X 5.5CM SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS ARTERIOVENOUS FISTULA LOCATED PROXIMALLY IN THE PATIENT¿S LEFT ARM. MODERATE VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. 90% STENOSIS REPORTED. NO DAMAGE NOTED TO DEVICE PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED A BURST OCCURRED ON THE CATHETER AT AN INFLATION PRESSURE OF 12ATM. THE DISTAL BALLOON AND CATHETER ARE REPORTED TO HAVE BURST AND DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED PORTIONS. AN IMAGE WAS TAKEN TO CONFIRM THE AV FISTULA WAS OPEN AFTER THE BALLOON ANGIOPLASTY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10013102 ↗