Quick-Cross Support Catheter 518-036 (UDI 00813132029364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132029364), received between Dec 5, 2023 and Mar 30, 2026 — classified as 2 injuries, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LEFT ILIAC ARTERY. A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS USED TO ATTEMPT TO CROSS THE LESION; HOWEVER, THE MARKER BAND BECAME DISLODGED IN THE PATIENT. A STENT WAS PLACED TO JAIL/TACK THE MARKER BAND TO THE VESSEL WALL. A SECOND QUICK-CROSS WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT CAPTURES THE QUICK-CROSS MARKER BAND THAT DETACHED AND REMAINED IN THE PATIENT, POTENTIAL FOR HARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24737371 ↗
• InjuryDec 26, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A NON-THROMBOTIC LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS EXPERIENCING CLAUDICATION, AND HAD AN EXISTING STENT PRESENT IN THE AREA. A PHILIPS QUICK-CROSS SUPPORT CATHETER WAS USED TO TREAT THE PATIENT. WHILE USING A CONTRALATERAL APPROACH AND CROSSING BEHIND THE EXISTING STENT, THE QUICK-CROSS GOT STUCK, AND BROKE OFF IN TWO PIECES. ONE PORTION OF THE QUICK-CROSS WAS SUCCESSFULLY SNARED; HOWEVER, THE SECOND PORTION COULD NOT BE RETRIEVED AND WAS STENTED WITHIN THE PATIENT. A SECOND QUICK-CROSS WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT CAPTURES THE QUICK-CROSS WHICH SEPARATED AT THE SHAFT, REQUIRING INTERVENTION, WITH A PORTION RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21021582 ↗
• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO PERFORM AN ARTERIOGRAM, LEFT LOWER EXTREMITY (LLE) ANGIOGRAM, AND STENT PLACEMENT TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN THE LEFT ILIAC ARTERY (PATIENT HAS GANGRENE IN HER LLE). A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS USED TO ATTEMPT TO CROSS THE LESION; HOWEVER, THE QUICK-CROSS MARKER BANDS BECAME DISLOGED AND MOVED OUT OF PLACE, BUT REMAINED ON THE CATHETER. THE SURGEON WAS ABLE TO MANIPULATE THE MARKER BANDS AND REMOVE THE DEVICE. A SECOND QUICK-CROSS WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION WHICH CAPTURES THE QUICK-CROSS MARKER BANDS THAT DETACHED BUT REMAINED ON DEVICE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562748 ↗
• MalfunctionMay 23, 2024

  ELDERLY FEMALE WITH HISTORY OF PERIPHERAL ARTERIAL DISEASE. CURRENTLY, SHE HAS GANGRENE OF LEFT LOWER EXTREMITY. PROCEDURE: INTERVENTIONAL RADIOLOGY ARTERIOGRAM, LEFT LOWER EXTREMITY ANGIOGRAM WITH STENT PLACEMENT TO LEFT COMMON ILIAC. DURING THE PROCEDURE, THE METAL MARKERS FOR CATHETER BECAME DISLODGED AND MOVED. SURGEON WAS ABLE TO MANIPULATE MARKERS WITHOUT HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, QUICK-CROSS (PER SITE REPORTER), WILL FOLLOW UP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19380552 ↗
• MalfunctionDec 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL CASE DETAIL OBTAINED (B)(6) 2023: THE QUICK-CROSS ADVANCED UP AND OVER A CALCIFIED BIFURCATION, WITH ONLY A SHORT SHEATH ON THE IPSILATERAL SIDE. THE PHYSICIAN WAS MANIPULATING A WIRE DOWN THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS REMOVING THE QUICK-CROSS CATHETER WHEN IT GOT STUCK COMING BACK OVER THE BIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271252 ↗