CrossCathRecalls & reported problems across all models
Cook Incorporated · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 4
We found 10 models of CrossCath by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2016 and Jun 29, 2023 — classified as 6 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Material Perforation” (7 reports).
4 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
CrossCath recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 8, 2019Terminated
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Z-0590-2020 · Root cause: Process control · Recall details · FDA record ↗
- Nov 8, 2019Terminated
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Z-0589-2020 · Root cause: Process control · Recall details · FDA record ↗
- Nov 8, 2019Terminated
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Z-0588-2020 · Root cause: Process control · Recall details · FDA record ↗
- Nov 8, 2019Terminated
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Z-0587-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported CrossCath problems
Device problems
- Material Perforation7
- Material Separation7
- Break6
- Stretched3
- Difficult to Advance2
- Hole In Material2
- Material Puncture/Hole2
- Peeled/Delaminated2
Patient problems
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions5
- No Code Available5
- Injury1
- Perforation of Vessels1
- Vascular Dissection1
CrossCath models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CrossCath G51577Catheter, continuous flush1 recall5 reports
- CrossCath G51583Catheter, continuous flush1 recall1 report
- CrossCath G51572Catheter, continuous flush1 recall0 reports
- CrossCath G51575Catheter, continuous flush1 recall0 reports
- CrossCath G51574Catheter, continuous flush7 reports
- CrossCath G51580Catheter, continuous flush7 reports
- CrossCath G51581Catheter, continuous flush7 reports
- CrossCath G51573Catheter, continuous flush2 reports
- CrossCath G18499Catheter, continuous flush1 report
- CrossCath G51582Catheter, continuous flush1 report
Recent CrossCath adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 15, 2022Material Perforation; Material Perforation
AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, AN UNSPECIFIED CTO WIRE PERFORATED A CROSSCATH SUPPORT CATHETER, MAKING A HOLE IN THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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 Clinical Signs, Symptoms or Conditions
MAUDE report 14702472 ↗MalfunctionMar 31, 2022Break; Peeled/Delaminated; Break; Peeled/Delaminated
AS REPORTED, A CROSSCATH SUPPORT CATHETER DELAMINATED. THE DEVICE WAS ATTEMPTED TO BE ADVANCED OVER A 0.018" WIRE GUIDE BUT COULD NOT DUE TO RESISTANCE. THE CATHETER BUNCHED, AND A FRAGMENT SEPARATED FROM THE CATHETER WHEN REMOVING FROM THE WIRE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 13967422 ↗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 ↗MalfunctionFeb 24, 2020Material Perforation; Material Perforation
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; Vascular Dissection
MAUDE report 9746083 ↗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 ↗MalfunctionMar 15, 2019Material Perforation; Material Perforation
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 8426093 ↗InjuryMar 7, 2019Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8399963 ↗MalfunctionMar 6, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
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 8395609 ↗InjuryFeb 26, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8370073 ↗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 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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page