EverCross™ AB35W06040135 (UDI 00763000766504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000766504), received between May 15, 2025 and Oct 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionOct 29, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 FOR TREATMENT OF A PLAQUE LESION IN THE MID LEFT COMMON ILIAC ARTERY, IT WAS NOTED THAT THE DEVICE WAS MISSING THE PROXIMAL BALLOON MARKER. THE SHEATH USED WAS A 7FR NON-MEDTRONIC SHEATH, AND THE VESSEL WAS BOTH PRE-DILATED WITH AN EVERCROSS 6X40 AND POST-DILATED WITH AN EVERCROSS 7X40. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE PHYSICIAN PROCEEDED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412779 ↗
• InjuryMay 15, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  A PATIENT PRESENTED FOR A PLANNED RIGHT LOWER EXTREMITY ANGIOGRAM WITH ANGIOPLASTY. DURING THE PROCEDURE, 2 EVERCROSS PTA BALLOON CATHETERS RUPTURED ON IRREGULAR PLAQUE LEADING TO SEEMING OCCLUSION OF THE DEEP FEMORAL BRANCH. THE FIRST EVERCROSS BALLOON AB35W06060135 HAD A PIN HOLE RUPTURE. THE SECOND EVERCROSS BALLOON AB35W06040135 ALSO HAD REMOVAL DIFFICULTIES. THERE WAS CONCERN FOR POTENTIAL RETAINED BALLOON MATERIAL. THE PROCEDURE WAS ABORTED, AND A VASCULAR SURGEON WAS CONSULTED. THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM SUITE FOR INTERVENTION. NO BALLOON FRAGMENTS WERE IDENTIFIED. AT THE TIME OF THE BALLOONS RUPTURING, THE INTERVENTIONAL RADIOLOGIST WAS NOT UTILIZING THE INSUFFLATOR AND ONLY USING APPROXIMATELY 8MM HG OF HAND PRESSURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025716 ↗