CrossCath G51581Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002515819), received between Jan 11, 2018 and Jun 29, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2023Material Perforation; Material Perforation

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY, A CROSSCATH SUPPORT CATHETER WAS PERFORATED BY AN UNSPECIFIED 0.038 OR 0.035-INCH, 260-CENTIMETER COONS WIRE GUIDE. THE CATHETER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY, AND THE USER WAS REPORTEDLY ADVANCING THE CATHETER FAR ENOUGH OVER A TIGHT BIFURCATION TO BE ABLE TO PLACE A SHEATH. UPON ADVANCING THE WIRE GUIDE, IT "POKED" THROUGH THE CATHETER. THE ANATOMY WAS BOTH TORTUOUS AND CALCIFIED, AND THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THE PATIENT'S DIFFICULT ANATOMY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226780 ↗
• MalfunctionNov 8, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THE CUSTOMER WAS PERFORMING A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION, USING THE CROSSCATH SUPPORT CATHETER TO CROSS A LESION. A COOK COONS WIRE WAS ADVANCED AND THE CROSSCATH SUPPORT CATHETER KINKED, OR CRACKED. THE COONS WIRE PERFORATED THE CROSSCATH SUPPORT CATHETER MID-WAY DOWN. ACCORDING TO THE REPRESENTATIVE, THERE WERE NO OTHER WIRES INSERTED INTO THE COMPLAINT DEVICE OTHER THAN THE COOK COONS WIRE. THE PHYSICIAN HAND INJECTED CONTRAST RATHER THAN USE A POWER INJECTOR AND NO DAMAGE TO THE VESSEL WALL WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051394 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE RADIOPAQUE MARKER SLID DOWN THE CROSSCATH SUPPORT CATHETER DURING A LEFT LOWER EXTREMITY ANGIOGRAM PROCEDURE FOR TREATMENT OF A CALCIFIED LESION. THE COMPLAINT DEVICE WAS PLACED IN THE RIGHT GROIN IN ORDER TO TREAT THE COMMON FEMORAL ARTERY. AN ANSEL SHEATH AND ROADRUNNER WIRE WERE BEING USED INSIDE THE COMPLAINT DEVICE AT THE TIME. NO ADDITIONAL PROCEDURES OR INTERVENTIONS WERE REQUIRED. NO ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7866120 ↗
• InjuryMay 8, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, ANOTHER MANUFACTURER'S GUIDE WIRE PERFORATED THE SIDE OF THE CROSSCATH SUPPORT CATHETER CAUSING DISSECTION OF THE PATIENT'S VESSEL. THE PATIENT'S VESSELS WERE SAID TO BE CALCIFIED. BLOOD LOSS COULD NOT BE QUANTIFIED AND BLOOD TRANSFUSION WAS NOT REPORTED. THE PHYSICIAN SURGICALLY REPAIRED THE VESSEL. ACCORDING TO THE INITIAL REPORTER, NO ADDITIONAL ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE; HOWEVER, THE ANGIOPLASTY PROCEDURE REPORTEDLY WILL NEED TO BE RESCHEDULED FOR COMPLETION.

  Patient problems: No Code Available; Perforation of Vessels

  MAUDE report 7496073 ↗
• MalfunctionMar 9, 2018Hole In Material; Kinked; Hole In Material; Kinked

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOPLASTY PROCEDURE, THE CROSSCATH SUPPORT CATHETER AND A COOK MEDICAL ROADRUNNER PC HYDROPHILIC WIRE GUIDE CROSSED A MID SUPERFICIAL FEMORAL ARTERY (SFA) CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) AND WERE ADVANCED TO THE POPLITEAL ARTERY. A WIRE GUIDE EXCHANGE TO ANOTHER MANUFACTURER'S 0.009 INCH DIAMETER ROTA WIRE GUIDE WAS ATTEMPTED; HOWEVER, DURING ADVANCEMENT OF THE NEW WIRE GUIDE, THE WIRE PROTRUDED THROUGH THE DISTAL TIP OF THE CATHETER AND WAS UNABLE TO ADVANCE FURTHER. A KINK/ HOLE WAS THOUGHT TO BE PRESENT AT THE END OF THE DISTAL END OF THE CATHETER SIDEWALL. THE CATHETER AND WIRE GUIDE WERE SIMULTANEOUSLY REMOVED, AND A NEW CATHETER AND WIRE GUIDE WERE UTILIZED TO CROSS THE PATIENT'S LESION WITH NO FURTHER ISSUES. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7328217 ↗
• InjuryFeb 13, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THAT DURING A RIGHT LOWER EXTREMITY ANGIOGRAM, ANOTHER MANUFACTURER'S GLIDE WIRE EXITED THE SIDE OF THE CROSSCATH SUPPORT CATHETER AS A HOLE WAS PRESENT. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS BROUGHT BACK ON ANOTHER DATE TO COMPLETE THE CASE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7267362 ↗
• MalfunctionJan 11, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAM, A FLEXOR ANSEL SHEATH (6 FR, 45 CENTIMETER (CM) LENGTH) WAS UP AND OVER THE AORTIC BIFURCATION. A COOK MEDICAL CONNORS WIRE GUIDE WAS ADVANCED THROUGH THE SHEATH INTO THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA), AND THE CROSSCATH SUPPORT CATHETER WAS ADVANCED OVER THE WIRE GUIDE TO THE DISTAL SFA. THE WIRE GUIDE WAS ATTEMPTED TO BE REMOVED AND BECAME STUCK ON THE CATHETER; THE WIRE GUIDE AND CATHETER WERE ABLE TO BE REMOVED TOGETHER. IT WAS NOTED THAT THERE WAS A HIGH AMOUNT OF TENSION PLACED ON THE CATHETER WHILE THE WIRE GUIDE WAS ATTEMPTED TO BE REMOVED. ANOTHER WIRE GUIDE AND CATHETER WERE THEN OPENED AND ADVANCED TO THE DISTAL SFA. FOLLOWING SUCCESSFUL COMPLETE OF THE PROCEDURE, THE CROSSCATH SUPPORT CATHETER HUB WAS OBSERVED TO BE SEPARATED. THE PATIENT WAS NOTED TO HAVE CALCIFIED VESSELS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7183432 ↗