EverCross™ AB35W07040080 (UDI 00763000184582)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000184582), received between Feb 12, 2020 and Aug 4, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Burst Container or Vessel; Burst Container or Vessel

  A HAWKONE ATHERECTOMY DEVICE WAS BEING USED FOR THE TREATMENT OF A CALCIFIED LESION WITH 60% STENOSIS IN THE COMMON ILIAC ARTERY AND  SUPERFICIAL FEMORAL ARTERY. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE IFU WAS FOLLOWED. A 6FR 55CM NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. IT WAS REPORTED THE ATHERECTOMY DEVICE HAD PLASTIC WRAPPED AROUND THE CUTTER WHEN IT WAS TAKEN OUT OF THE SHEATH. IT LOOKED TO BE THE INNER COATING OF THE 6FR SHEATH. A NEW 6 FR SHEATH WAS PUT IN AND THEN A BALLOON WAS USED TO POST DILATATE THE LESION. AN EVERCROSS WAS BEING USED AND THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN AC3200 MEDTRONIC INFLATION DEVICE WAS USED. IT WAS REPORTED THE BALLOON BURST AT 10 ATM DURING SECOND INFLATION. ALL FRAGMENTS WERE NOT RETRIEVED, THE PHYSICIAN USED A VISI-PRO STENT TO  COVER THE BALLOON FRAGMENT IN THE COMMON ILIAC. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WE MET DURING ADVANCEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457912 ↗
• MalfunctionSep 24, 2022Leak/Splash; Leak/Splash

  A PHYSICIAN WAS USING A EVERCROSS PTA BALLOON CATHETER FOR TREATMENT OF A CALCIFIED LESION WITH 70% STENOSIS IN THE MID RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE FIRST BALLOON INFLATION A PINHOLE LEAK WAS OBSERVED AT AN UNKNOWN ATM. ANOTHER EVERCROSS WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476408 ↗
• MalfunctionAug 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER ALONG WITH A NON-MEDTRONIC 5FR SHEATH TO TREAT A LESION IN THE FISTULA. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON INFLATED, DEFLATED AND UPON REMOVAL, DISTAL TIP OF BALLOON DETACHED FROM ASSEMBLY. DISTAL TIP REMAINED ADHERED TO GUIDEWIRE AND WAS REMOVED WITHOUT ANY FOREIGN BODY REMAINING IN PATIENT. THE DETACHMENT OCCURRED AT THE TIP. GUIDEWIRE REMOVAL VIA CONVENTIONAL MEANS (DISTAL TIP NEVER SEPARATED FROM GUIDEWIRE, ONLY BALLOON SHAFT). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PROCEDURE WAS COMPLETED VIA INFLATION, DEFLATION AND BALLOON REMOVAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299777 ↗
• MalfunctionJun 4, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED AN EVERCROSS PTA BALLOON DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE S NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT IS REPORTED A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING BALLOON INFLATION AT 14ATM. THE BALLOON DID NOT FRAGMENT, NO INTERVENTION REQUIRED FOR REMOVAL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937774 ↗
• InjuryFeb 12, 2020Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED AN EVERCROSS PTA BALLOON CATHETER ALONG WITH A 6FR SHEATH AND NON MEDTRONIC GUIDE WIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID COMMON ILIAC ARTERY. THERE WERE NO DAMAGES TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM HOOP/TRAY. IT WAS REPORTED THAT DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON BURST OCCURRED AT AN UNKNOWN ATM. DURING ATTEMPT TO REMOVE FROM VESSEL, BALLOON COMPONENT DETACHED AT THE TIP AND BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PATIENT WAS SENT FOR SURGERY TO RETRIEVE BALLOON FRAGMENT. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 9700023 ↗