CROSSLEAD CLN03530ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327140195), received between Jan 19, 2023 and Dec 19, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AN ANGIOGRAPHIC EXAMINATION OF THE POPLITEAL ARTERY WAS PERFORMED. A 4F SHEATH WAS USED FOR PUNCTURE FROM RIGHT COMMON FEMORAL ARTERY AND WAS THEN EXCHANGED FOR A 6F SHEATH. AN ASAHI CROSSLEAD GUIDE WIRE AND A NON-ASAHI 5F ANGIOGRAPHIC CATHETER WERE USED TO ACCESS OVER THE BIFURCATION. THE CROSSLEAD GUIDE WIRE WAS ADVANCED DOWN THE LEFT COMMON ILIAC ARTERY, THROUGH THE LEFT EXTERNAL ILIAC ARTERY INTO THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5F ANGIOGRAPHIC CATHETER WAS THEN REMOVED AND A NON-ASAHI 6F SHEATH WAS INSERTED. A NON-ASAHI SUPPORT CATHETER WAS ADVANCED ON THE CROSSLEAD GUIDE WIRE AND WAS DELIVERED OVER THE BIFURCATION INTO THE LEFT COMMON FEMORAL ARTERY. WHEN ATTEMPTS WERE MADE TO REMOVE THE CROSSLEAD GUIDE WIRE, RESISTANCE WAS FELT. THE GUIDE WIRE WAS THEN REMOVED TOGETHER WITH THE SUPPORT CATHETER. AFTER REMOVAL OF THE GUIDE WIRE FROM THE CATHETER, THE GUIDE WIRE WAS FOUND DAMAGED. A NEW CATHETER WAS THEN USED AND THE PROCEDURE WAS COMPLETED. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AND DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847370 ↗
• MalfunctionDec 11, 2025Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  R CFA WITH 4FR MICRO PUNCTURE KIT. INTRODUCER EXCHANGED FOR 6FR X 11CM PINNACLE SHEATH OVER THE CROSSLEAD PRO .035 X 300CM., .035 X 90 CM AND A 5FR SOS REVERSE CURVE CATHETER WAS USED TO ACCESS OVER THE BIFURCATION. CROSSLEAD WIRE WAS ADVANCED DOWN THE LEFT COMMON ILIAC, THROUGH THE LEFT EXTERNAL ILIAC INTO THE LEFT SUPERFICIAL FEMORAL ARTERY. 5FR SOS CATHETER WAS REMOVED AND 6FR X 65CM COOK SHEATH WAS INSERTED THEN A .035 X 90CM STRAIGHT TIP TRAILBLAZER WAS ADVANCED OVER THE BIFURCATION INTO THE LEFT COMMON FEMORAL ARTERY. UPON TRYING TO REMOVE THE CROSSLEAD, THERE WAS A LOT OF RESISTANCE PULLING THE WIRE BACK. ONCE THE WIRE WAS OUT OF THE CATHETER, THEY NOTICED THE INTEGRITY OF THE WIRE WAS COMPROMISED. NO ISSUES PRIOR TO THE TRAILBLAZER BEING USED. IT WAS A SUCCESSFUL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783485 ↗
• MalfunctionNov 11, 2025Crack; Flaked; Crack; Flaked

  WIRE WAS USED FOR ACCESS VIA LEFT COMMON FEMORAL ARTERY TO GO UP & OVER THE AORTIC BIFURCATION INTO THE LEFT ILIAC & LEFT COMMON FEMORAL ARTERY. UPON REMOVAL OF THE WIRE FROM THE BODY, THE SURGICAL TECH NOTICED AN ENLARGED GAP BETWEEN DISTAL WIRE TIP COVERING AND PROXIMAL SHAFT. WHILE MANIPULATING THE WIRE OUTSIDE OF THE BODY, A PART OF THE DISTAL WIRE TIP COATING CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526621 ↗
• InjuryJan 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE UNSPECIFIED LESION IN THE SEVERELY TORTUOUS LIMB ARTERY. THE MICROCATHETER WAS NAVIGATED OVER THE BIFURCATION AND PARKED IN THE ILIAC ARTERY. THE CROSSLEAD GUIDE WIRE WAS INSERTED INTO THE NAVICROSS SUPPORT CATHETER. AFTER TWO MINUTES OF MANIPULATION THE WIRE GOT STUCK. THE WHOLE SYSTEM NEEDED TO BE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244783 ↗
• MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MICROCATHETER WAS NAVIGATED OVER THE FIFURCATION AND PARKED IN THE ILLIAC. THE CROSSLEAD WAS INSERTED INTO THE NAVICROSS. AFTER TWO MINUTES OF MANIPULATION THE WIRE GOT STUCK. THE WHOLE SYSTEM NEEDED TO BE REMOVED FROM THE PATIENT. NO PATIETN COMPLICATIONS. THE TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209884 ↗