EverCross™ AB35W05150135 (UDI 00763000184278)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000184278), received between Sep 15, 2021 and Aug 31, 2023 — 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Burst Container or Vessel; Burst Container or Vessel

  AN EVERCROSS PTA BALLOON WAS INTENDED TO BE USED FOR TREATMENT OF A 100MM PLAQUE LESION WITH 70% STENOSIS IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 5MM IN DIAMETER WITH MILD CALCIFICATION AND NO TORTUOSITY. A 6FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED USING A SYRINGE, WITH A MIXTURE OF SALINE AND CONTRAST MEDIA. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE HAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THE BALLOON HAD A CIRCUMFERENTIAL/RADIAL BURST AT 10ATM, THE FIRST FILLING JUST REACHED THE NAMED PRESSURE AND IT RUPTURED. ALL FRAGMENTS WERE RETRIEVED, THE BALLOON RUPTURED AND THE FRAGMENTS DID NOT COME OFF THE BODY OF THE BALLOON, SO ALL THE FRAGMENTS WERE REMOVED ON THE BALLOON WITH THE CATHETER ATTACHED. NO VESSEL INJURY WAS NOTED. ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660679 ↗
• MalfunctionJan 11, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT LESION IN PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. A NON MEDTRONIC 6 FR SHEATH WAS USED. 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. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 5 ATM. THIS WAS REPORTED FOR TWO BALLOONS. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222713 ↗
• InjuryOct 22, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE DISTAL MID PR OXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD MODERATE TORTUOSITY AND CTO (CHRONIC TOTAL OCCLUSION-100%). THE ARTERY DIAMETER WAS 5MM AND LESION LENGTH WAS 25CM. NON-MEDTRONIC 6FR 45CM SHEATH AND 45CM GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THERE WERE BALLOON DEFLATION DIFFICULTIES AND DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DEFLATION ISSUES NOTED DURING SUBSEQUENT INFLATION. THE EVERCROSS 5 X 150 WAS INSERTED OVER A NON-MEDTRONIC GUIDEWIRE 0.035'' WIRE TO TREAT LONG SFA CTO. INITIALLY INFLATED TO 2 ATM WITH NO ISSUES. AFTER SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. THEY TRIED NEGATIVE, UNHOOKED INFLATION DEVICE BUT COULD NOT DEFLATE. THEY USED 0.014'' WIRE TO POP BALL

  Patient problems: Insufficient Information

  MAUDE report 12679373 ↗
• MalfunctionSep 15, 2021Inflation Problem; Inflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE EVERCROSS PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. A PRESSURE PUMP WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES WAS OBSERVED DURING BALLOON INFLATION AT 12ATM. NO BALLOON BURST OCCURRED. NO LEAK PRESENT. NO BALLOON DAMAGE NOTED. BALLOON WAS UNDER INFLATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. BALLOON WAS SAFELY REMOVED FROM PATIENT. ANOTHER BALLOON OF THE SAME MODEL WAS REPLACED WITH, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE BALLOON WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475261 ↗