CXI G52547Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002525474), received between May 27, 2016 and Dec 13, 2024 — classified as 7 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923693 ↗
• InjuryMar 15, 2024Break; Break

  AS REPORTED, DURING AN OUTPATIENT INTERVENTIONAL PROCEDURE INVOLVING ANGIOPLASTY AND PLACEMENT OF A STENT FOR REVASCULARIZATION OF A LOWER LIMB, TWO CXI SUPPORT CATHETERS SEPARATED. ANOTHER MANUFACTURER'S INTRODUCER AND WIRE GUIDE WERE USED TO ACCESS THE FEMORAL ARTERY AND RETROGRADE ACCESS WAS OBTAINED WITH ANOTHER MANUFACTURER'S WIRE GUIDE. THE FIRST CXI CATHETER WAS ADVANCED INTO THE FEMORAL ARTERY; HOWEVER, THE CATHETER REPORTEDLY BECAME STUCK/TRAPPED IN THE PATIENT. THE SURGEON THEN REMOVED THE CATHETER BUT DISCOVERED VIA "AMPLIFIER HIGHLIGHT" THAT PART OF THE DEVICE HAD SEPARATED IN THE ARTERY. AFTER "SEVERAL MANIPULATIONS", THE SEPARATED FRAGMENT WAS REMOVED FROM THE PATIENT. A SECOND CXI CATHETER (FROM THE SAME LOT) WAS THEN USED; HOWEVER, THAT CATHETER ALSO SEPARATED. A FRAGMENT OF THE SECOND CATHETER REMAINS IN THE PATIENT'S ARTERY, AS IT WAS IMPOSSIBLE TO REMOVE WITHOUT OPENING THE PATIENT. REPORTEDLY, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18918740 ↗
• InjuryAug 29, 2023Break; Break

  AS REPORTED, DURING A FENESTRATED ENDOVASCULAR REPAIR PROCEDURE, A CXI SUPPORT CATHETER SEPARATED. THE CATHETER WAS REPORTEDLY INSERTED INTO AN AORTIC GRAFT THAT WAS ALREADY IN SITU, RESULTING IN SEPARATION OF THE DISTAL PORTION OF THE CATHETER, WHICH WAS RETAINED IN THE PATIENT. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR FURTHER SURGERY AT A LATER TIME, WHERE THE CATHETER WAS SUCCESSFULLY REMOVED WITH A SNARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17641863 ↗
• MalfunctionApr 12, 2022Break; Break

  AS REPORTED, DURING A VENOGRAM, A CXI SUPPORT CATHETER SEPARATED AT THE HUB. THE DEVICE BECAME "STUCK" WITHIN THE LEFT POPLITEAL VEIN AFTER CROSSING THE LESION. THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DEVICE. UPON RETURN EVALUATION OF THE DEVICE 15MAR2022, A SMALL SEPARATED PORTION OF THE CATHETER SHAFT REMAINED INSIDE THE HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083385 ↗
• MalfunctionSep 1, 2021Material Perforation; Material Perforation

  ADDITIONAL INFORMATION WAS RECEIVED 02SEP2021. THE ACCESS SITE WAS THE RIGHT ILIAC ARTERY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE KINK AND PERFORATED DEVICE HAPPENED AT THE END OF THE PROCEDURE. THE PATIENT'S OUTCOME WAS "OKAY."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405981 ↗
• MalfunctionMay 18, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 11840479 ↗
• MalfunctionMar 5, 2021Material Perforation; Material Perforation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11420390 ↗
• MalfunctionJun 12, 2020Material Frayed; Material Frayed

  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 10150232 ↗
• MalfunctionMar 3, 2020Material 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 Consequences Or Impact To Patient

  MAUDE report 9780882 ↗
• MalfunctionJan 18, 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 Consequences Or Impact To Patient

  MAUDE report 8261055 ↗
• MalfunctionSep 12, 2018Material Separation; Material Separation

  A MALE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE OF THE INTERNAL ILIAC ARTERY (IIA) VIA THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS UNABLE TO ADVANCE ANOTHER MANUFACTURER'S ANGIOPLASTY CATHETER DUE TO CALCIFICATION OF THE PATIENT'S ANATOMY. IT WAS REPLACED WITH A CXI SUPPORT CATHETER WHICH WAS ABLE TO ADVANCE "A LITTLE BIT," BUT MET WITH THE SAME DIFFICULTY. IT WAS REPORTED TORQUE WAS APPLIED TO THE CXI SUPPORT CATHETER IN AN ATTEMPT TO ADVANCE IT FURTHER WHEN IT BROKE IN THE PATIENT'S ANATOMY. THE SEPARATED PORTION OF THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT VIA AN UNSPECIFIED SNARE DEVICE. THE PROCEDURE WAS ABORTED AT THIS POINT. NO INFORMATION WAS PROVIDED REGARDING IF OR WHEN IT WILL BE RE-SCHEDULED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING RESCHEDULING OF THE PROCEDURE HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Code Available

  MAUDE report 7870354 ↗
• MalfunctionMay 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED A HAIR WAS FOUND INSIDE THE SEALED CXI SUPPORT CATHETER PACKAGE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE UNSPECIFIED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS RESULT OF THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7496433 ↗
• InjuryMar 6, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN OPEN LEFT COMMON ILIAC ARTERY (CIA) REPAIR AND ANGIOGRAM, THE TIP OF THE CXI SUPPORT CATHETER BROKE OFF INSIDE OF THE PATIENT'S ANATOMY. THE CATHETER TIP WAS ABLE TO BE SUCCESSFULLY RETRIEVED USING A SNARE. 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 Code Available

  MAUDE report 7317442 ↗
• InjuryNov 15, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE CXI SUPPORT CATHETER (4.0 FR GAUGE) TIP CAME OFF WHEN ATTEMPTING TO LOAD THE CATHETER ON A 0.35 INCH DIAMETER WIRE GUIDE. THE PHYSICIAN SWITCHED TO A 0.18 INCH DIAMETER WIRE GUIDE SYSTEM, AND UTILIZED A CXI-2.6-18-90-ANG (2.6 FR GAUGE) CATHETER INSTEAD. 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 Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7035582 ↗
• MalfunctionNov 7, 2017Fluid/Blood Leak; Device Contamination with Chemical or Other Material

  THE DEVICE WAS USED FOR ENDOVASCULAR TREATMENT (EVT). A WIRE GUIDE STOPPED ADVANCING THROUGH THE CXI AT A CERTAIN POINT. THEN, ANOTHER LOT# WAS USED INSTEAD TO FINISH THE PROCEDURE. IT WAS NOTED THAT WHEN A WIRE GUIDE WAS INSERTED INTO THE CXI, A CLEAR LIQUID CAME OUT, AS WELL AS SOME BLACK FOREIGN MATTER FROM THE TIP. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005996 ↗
• MalfunctionOct 31, 2017Device Operates Differently Than Expected

  IT WAS NOTED THAT ANOTHER MANUFACTURER'S GUIDE WIRE DIDN'T EXIT AT THE END OF THE CXI CATHETER BUT WAS RUNNING BESIDE THE CATHETER FROM THE LEVEL OF A RADIOPAQUE MARKER. IT WAS FURTHER NOTED THAT THE CATHETER WAS SEPARATED AND THERE WAS A SMALL HOLE IN THE CATHETER MATERIAL. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991331 ↗
• MalfunctionOct 31, 2017Material Integrity Problem

  ITEM WAS REMOVED FROM THE PACKAGING AND THEN FLUSHED. DURING THIS TIME IT WAS NOTED THAT THE HYDROPHILIC COATING WAS COMING OFF. DISCREPANCY DISCOVERED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6991210 ↗
• MalfunctionOct 31, 2017Difficult to Insert; Material Deformation

  THE CUSTOMER REPORTED THE THEY GAINED ACCESS FROM THE LEFT COMMON FEMORAL ARTERY TO THE LESION OF THE SUPERIOR FEMORAL ARTERY (SFA) IPSILATERALLY. THE CXI CATHETER WOULD NOT PASS THROUGH THE LESION, AND THE USER ATTEMPTED TO ADVANCE IT SEVERAL TIMES. THEN, THE TIP OF THE CXI BECAME FLARED, AND IT WAS IMPOSSIBLE TO PASS THROUGH THE LESION. THEREFORE, ANOTHER LOT OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Information

  MAUDE report 6989821 ↗
• MalfunctionJul 25, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM INTERVENTION, THE PROXIMAL HUB OF THE CXI SUPPORT CATHETER DETACHED. THE CATHETER WAS REMOVED BY HAND AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT AND THERE WAS NO REPORTED ADVERSE EVENT OR INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6739785 ↗
• InjuryOct 13, 2016Break; Break

  IT WAS REPORTED DURING A FENESTRATED ZENITH PROCEDURE THE TIP BROKE OFF THE CXI SUPPORT CATHETER BEING USED TO CATHETERIZE THE TRUNCUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE IF ANY FRAGMENTS REMAINED IN THE PATIENT. 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 6028301 ↗
• MalfunctionSep 16, 2016Split; Split

  IT WAS REPORTED THAT A CATHETER SPLIT DURING A VENOGRAM PROCEDURE ON A FEMALE PATIENT. ONCE REMOVED IT WAS NOTICED THAT THE CATHETER HAD A SPLIT IN IT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5956312 ↗
• InjuryJun 13, 2016Break; Break

  DURING A TIPS PLACEMENT (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) THE TIP OF THE PRODUCT BROKE AND BECAME STUCK IN THE LIVER. THE CATHETER WAS EXTRACTED AND THE TIP WAS RETRIEVED WITH A SNARE FROM THE PATIENT. 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

  MAUDE report 5720608 ↗
• InjuryMay 27, 2016Kinked; Kinked

  DURING A RECANALIZATION PROCEDURE ON THE (B)(6) YEAR OLD FEMALE PATIENT, THE DOCTOR WAS ATTEMPTING TO CROSS A CALCIFIED VESSEL, USING THE COOK CXI CATHETER. HOWEVER, THE CATHETER KINKED, DISSECTING THE VESSEL. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS EVENT AS A STENT WAS PLACED DUE TO THE VESSEL DISSECTION. ADDITIONAL INFORMATION PROVIDED ON 12 MAY 2016: THE SURGEON WAS PUSHING THE CATHETER TIP AGAINST A VERY HARD CALCIFIED LESION AND COULD NOT ADVANCE THE CATHETER. THE SURGEON THEN DID A RUN THROUGH THE SHEATH AND DISCOVERED THAT THE VESSEL HAD DISSECTED DISTALLY TO THE LESION ITSELF, EVEN THOUGH HE HAD NOT YET MANAGED TO CROSS THE LESION. HE THEN TRIED TO RE-ADVANCE THE WIRE THROUGH THE CATHETER AND HE DISCOVERED THE KINK IN THE SHAFT. THE SURGEON FEELS THE CATHETER MAY HAVE KINKED BELOW THE LEVEL OF HIS WIRE AS HE WAS PUSHING ON THE LESION. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT.

  Patient problems: Vascular Dissection

  MAUDE report 5686282 ↗