CROSSLEAD Penetration CLP01430SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327143875), received between Aug 18, 2025 and Aug 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED FOR A HEAVILY CALCIFIED AND MILDLY FLEXUOUS CHRONIC TOTAL OCCLUSIONS (CTO) FOR THE SECOND TIME AS THE PAST PROCEDURE HAD FAILED. WHEN AN ASAHI CROSSLEAD PENETRATION GUIDE WIRE WAS ANTEGRADELY MANIPULATED, THE DISTAL SEGMENT OF THE GUIDE WIRE GOT FRACTURED. THE WIRE FRAGMENT WAS LEFT IN SITU, AND THE PROCEDURE WAS FINISHED. IT WAS REPORTED THAT THE PHYSICIAN SUGGESTED A BYPASS SURGERY FOR REVASCULARIZATION TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22901776 ↗MalfunctionAug 18, 2025Material Fragmentation; Material Fragmentation
WHILE TORQUING WIRE IN CALCIFIED A.T. DISTAL TIP OF WIRE CAME OFF. LEFT IN PATIENT, NO INJURY BUT HAVE DEVICE TO RETURN. RETURNING WIRE - WAS IN BODY AND NOT RESTERILIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22833370 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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