CROSSWALK PSC18150ARecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547327133524), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Break; Device Dislodged or Dislocated
LOWER EXTREMITY ANGIOGRAM ON PATIENT WITH KNOWN DISEASE (HIGHLY CALCIFIED) OSTEOMYELITIS OF RIGHT GREAT TOE-ATTEMPT FOR REVASCULARIZATION. CROSSWALK SUPPORT CATHETER TIP BROKE OFF IN THE CALCIUM OF RIGHT TIBIAL ARTERY. DURING PERIPHERAL INTERVENTION DISTAL END OF PLASTIC CATHETER BECAME DISLODGED FROM CATHETER SHEATH. TIP OF DEVICE IMBEDDED IN CALCIUM IN VESSEL, UNABLE TO SNARE OR REMOVE. PHYSICIAN DEEMED IT SAFE, DUE TO LOCATION TO LEAVE IMBEDDED IN VESSEL.
Patient problems: Foreign Body In Patient
MAUDE report 22737028 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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