CROSSWALK PSC35170ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327133630), received between Sep 18, 2025 and Sep 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 19, 2025Break; Break

  THE CROSSWALK BROKE INTO 2 PIECES BY OVER TORQUING THE CATHETER WHILE TRYING TO CROSS THE RIGHT SFA. THE PHYSICIAN SAID HE OVER TORQUED THE CATHETER. THE DEVICE WAS ABLE TO BE REMOVED BY PULLING THE SHEATH OUT WHILE THE CROSSWALK WAS STILL IN THE SHEATH. THE PHYSICIAN THEN PULLED EVERYTHING BACK IN THE SHEATH AND ALL COMPONENTS WERE REMOVED INCLUDING BOTH PIECES OF THE CROSSWALK. THERE WAS NO HARM TO THE PATIENT. EVERYTHING WAS REMOVED FROM THE BODY AND PRESSURE WAS HELD ON THE RADIAL ARTERY FOR ACCESS CLOSURE. PATIENT DID FINE. PATIENT DID FINE. PATIENT WAS DISCHARGED IN NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096854 ↗
• MalfunctionSep 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ASAHI CROSSWALK SUPPORT CATHETER WAS USED FOR A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO CROSS A MODERATELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). AS EXCESSIVE TORQUE WAS APPLIED, THE SUBJECT CROSSWALK SUPPORT CATHETER WAS SEPARATED. AS THE SUPPORT CATHETER WAS LOCATED IN AN UNSPECIFIED CONCOMITANT SHEATH, THE PHYSICIAN PULL ALL OF THE DEVICES INCLUDING THE SEPARATED CROSSWALK SUPPORT CATHETER PIECES AND REMOVED EX SITU. THE PHYSICIAN COMMENTED THAT HE OVER-TORQUED THE CROSSWALK SUPPORT CATHETER. IT WAS INFORMED THAT THERE WAS NO HEALTH HAZARDS CAUSED BY THE EVENT, AND THE PATIENT WAS DISCHARGED. AS THE SCHEDULED PROCEDURE HAD BEEN HALTED JUST BEFORE THE REPORTED EVENT OCCURRED, ANOTHER PROCEDURE WAS SCHEDULED TO ACCESS FROM A DIFFERENT SITE AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081154 ↗