Quick-Cross Support Catheter 518-065 (UDI 00813132029395)Recalls & reported problems
Philips Image Guided Therapy Corporation · Class 2
Data updated Oct 18, 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 00813132029395), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Material Separation; Material Separation
A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND CHRONIC TOTAL OCCLUSION (CTO) IN THE POPLITEAL ARTERY/TIBIOPERONEAL TRUNK. A PHILIPS QUICK-CROSS SUPPORT CATHETER WAS USED TO TREAT THE PATIENT. WHILE USING A CONTRALATERAL APPROACH, HEMOSTATS WERE USED TO CLAMP DOWN THE TERUMO 0.014 GUIDEWIRE, BUT THE QUICK-CROSS GOT CLAMPED AS WELL. UPON REMOVAL OF THE QUICK-CROSS, RESISTANCE WAS MET BUT PULLING CONTINUED. AT THAT TIME, THE QUICK-CROSS BROKE, AND REMAINED ON THE GUIDE WIRE. THE HEMOSTATS WERE REMOVED, AND WHEN ATTEMPTING TO PUSH THE GUIDEWIRE FURTHER THROUGH THE INTRODUCER SHEATH AND REMOVING THE QUICK-CROSS OFF THE GUIDEWIRE, THE DEVICE CONTINUED TO BREAK INTO SEVERAL PIECES. HOWEVER, ALL OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BALLOON AND SHOCKWAVE DEVICE. NO PATIENT INJURY REPORTED. THIS REPORT CAPTURES THE QUICK-CROSS WHICH SEPARATED AT THE SHAFT, POTENTIAL FOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22442833 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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