CrossCath G51580Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002515802), received between Jan 11, 2018 and Aug 9, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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.

• MalfunctionAug 9, 2021Material Perforation; Material Perforation

  ADDITIONAL INFORMATION WAS RECEIVED 16SEP2021. THE EVENT OCCURRED AT THE BEGINNING OF THE PROCEDURE, AS THE USER WAS TARGETING THE LESION. THE ILIAC ARTERY WAS NOT TORTUOUS OR CALCIFIED. FLUIDS WERE INFUSED ONLY ONCE WITH A SYRINGE; A POWER INJECTOR WAS NOT USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294681 ↗
• MalfunctionJun 8, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962068 ↗
• MalfunctionJun 20, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING A PERIPHERAL INTERVENTION PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, AN UNKNOWN MANUFACTURER'S "GLIDEWIRE" PUNCTURED A PREVIOUSLY KINKED CROSSCATH SUPPORT CATHETER. THE CATHETER WAS REPORTEDLY ADVANCED THROUGH A COOK 7 FRENCH BALKIN SHEATH OVER THE UNKNOWN WIRE IN AN ATTEMPT TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) IN THE COMMON FEMORAL ARTERY. THERE WAS AN ANGLE "BEFORE" THE CTO THAT CAUSED THE CATHETER TO KINK. THE PHYSICIAN PULLED THE CATHETER OUT OF THE BODY AND STRAIGHTENED THE CATHETER. THE PHYSICIAN RE-INSERTED THE CATHETER OVER THE WIRE THROUGH THE SAME SHEATH. WHEN THE PHYSICIAN PULLED THE WIRE BACK AND ADVANCED IT AGAIN, THE WIRE PUNCTURED THROUGH THE SIDE OF THE CATHETER AT THE LOCATION OF THE ORIGINAL KINK. THE PHYSICIAN REMOVED THE DEVICE WHEN IT WAS OBSERVED THAT THE WIRE WAS NOT IN THE CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 8716190 ↗
• MalfunctionMar 27, 2019Material Separation; Stretched; Material Separation; Stretched

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457165 ↗
• MalfunctionSep 19, 2018Structural Problem; Structural Problem

  DURING A LEFT LEG ANGIOPLASTY PROCEDURE, IT WAS REPORTED, A CROSSCATH SUPPORT CATHETER WAS ADVANCED OVER A TIGHT ANGLE/STEEP BIFURCATION IN THE PATIENT'S ANATOMY . NO SCARRING OF THE ACCESS SITE OR CALCIFICATION OF THE VASCULATURE WAS REPORTED. A HIWIRE HYDROPHILIC WIRE GUIDE WAS ACTIVATED WITH HEPARINIZED SALINE AND ADVANCED THROUGH THE CATHETER BUT PERFORATED THROUGH THE CATHETER AT THE POINT OF THE STEEP BIFURCATION. A KINK WAS NOTED IN THE CROSSCATH SUPPORT CATHETER. THESE TWO DEVICES WERE REMOVED FROM THE PATIENT AND A CXI SUPPORT CATHETER WAS THEN USED AND KINKED AT THE BIFURCATION AS WELL. THIS DEVICE WAS REMOVED AND THE PROCEDURE WAS ABORTED. PER THE COMPLAINANT THE PROBABLE CAUSE FOR DEVICE FAILURES WAS PATIENT ANATOMY. PER THE COMPLAINANT, THE PROCEDURE WILL NOT BE RESCHEDULED. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED. UPON RECEIPT OF THE CROSSCATH SUPPORT CATHETER BY THE MANUFACTURER, A PRELIMINARY VISUAL INSPECTION SHOWED THE KINK RESULTED IN SHARP EDGES WHICH COULD RESULT IN PATIENT INJURY; THEREFORE, THIS REPORT IS BEING SUBMITTED. PLEASE REFERENCE ALSO 1820334-2018-02689 WHICH REPORTS THE ABORTED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7889487 ↗
• MalfunctionAug 2, 2018Material Perforation; Difficult to Advance; Material Perforation; Difficult to Advance

  IT WAS REPORTED, THE CROSSCATH SUPPORT CATHETER PERFORATED DURING A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY PROCEDURE. DIFFICULT ADVANCEMENT WAS EXPERIENCED WHEN ATTEMPTING TO CROSS THE LESION. UPON REMOVING THE CATHETER AND A .035 X 180 CENTIMETER UNIGLIDE (COOK MEDICAL) WIRE, THE LAB MANAGER NOTICED THE WIRE HAD PERFORATED THROUGH THE DISTAL END OF THE CATHETER. REPORTEDLY, THERE WAS NO DEFECT NOTED WITH THE UNIGLIDE WIRE. ANOTHER CROSSCATH SUPPORT CATHETER WAS SUCCESSFULLY ADVANCED OVER THE WIRE TO COMPLETE THE PROCEDURE. 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 Known Impact Or Consequence To Patient

  MAUDE report 7744415 ↗
• InjuryJan 11, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN AORTIC ANEURYSM REPAIR WITH A FENESTRATED GRAFT, THE CROSSCATH SUPPORT CATHETER WAS ADVANCED OVER THE GLIDEWIRE INTO THE PATIENT'S LEFT RENAL ARTERY IN ORDER TO PERFORM A WIRE EXCHANGE. THE GLIDEWIRE WAS ABLE TO BE REMOVED, AND WAS REPLACED WITH A ROSEN WIRE GUIDE. UPON ADVANCING THE ROSEN WIRE GUIDE THROUGH THE CROSSCATH SUPPORT CATHETER, THE CATHETER BROKE AT THE MARKER MOST DISTAL TO THE CATHETER TIP. A STIFF GLIDEWIRE WAS USED TO RETRIEVE THE CATHETER FROM THE RENAL ARTERY. ALL WIRES UTILIZED DURING THE PROCEDURE WERE NOTED TO HAVE A 0.035 INCH DIAMETER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7183626 ↗