CROSSWALK PSC18090ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327133494), received between Aug 10, 2021 and Aug 26, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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.

• InjuryAug 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CROSSWALK PERIPHERAL SUPPORT CATHETER HAD BROKEN OFF IN A COLLATERAL BRANCH OF THE TIBIAL ARTERY DURING A PERIPHERAL INTERVENTION TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION (CTO) IN THE MID TIBIAL ARTERY. WHILE ATTEMPTING TO BRING THE CROSSWALK UP FROM THE PEDAL SHEATH OVER A NON-ASAHI V-18 GUIDE WIRE, FORCE WAS APPLIED AGAINST RESISTANCE. THE TIP OF THE CROSSWALK GOT DIRECTED INTO A SMALL BRANCH AND GOT STUCK AND WAS LEFT IN THE SMALL VESSEL OFF THE LEFT TIBIAL. THE PHYSICIAN DID NOT ATTEMPT TO RECOVER THE TIP AS IT WENT INTO A COLLATERAL. THE DOCTOR SWITCHED TO A NON-ASAHI CXI SUPPORT CATHETER AND THERE WAS NO SIGNIFICANT DELAY TO THE CASE. THE PATIENT OUTCOME WAS NORMAL. THE PROCEDURE WAS FINISHED AND ALL WAS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12375536 ↗
• InjuryAug 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A CROSSWALK PERIPHERAL SUPPORT CATHETER FELL OFF DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TO TREAT MILDLY TORTUOUS, MILDLY CALCIFIED, RANDOM LESIONS IN THE SUPERFICIAL FEMORAL ARTERY, TIBIAL ARTERY, AND POPLITEAL ARTERY. THE PHYSICIAN DETERMINED TO LEAVE THE SEPARATED TIP IN SITU. THE PROCEDURE ITSELF HAD COMPLETED WITHOUT DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12368752 ↗
• InjuryAug 12, 2021Physical Resistance/Sticking

  WHILE ATTEMPTING TO BRING THE CROSSWALK UP FROM THE PEDAL SHEATH THE TIP OF THE CROSSWALK GOT DIRECTED INTO A SMALL BRANCH AND THE TIP GOT STUCK AND WAS LEFT IN THE SMALL VESSEL OFF THE LEFT TIBIAL. IT WAS ON A V-18 WIRE AT THE TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12316472 ↗
• InjuryAug 10, 2021Detachment of Device or Device Component

  THE CATHETER TIP FELL OFF DURING A RANDOM SFA PROCEDURE. NOT OVERLY CALCIFIED OR TORTOUS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12303167 ↗