CXI G52543Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002525436), received between Dec 1, 2016 and Apr 18, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA), ANOTHER MANUFACTURER¿S 0.035-INCH WIRE BECAME STUCK IN A CXI SUPPORT CATHETER. IPSILATERAL ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE POPLITEAL ARTERY. THE CXI WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S 5-FRENCH SHEATH, AND THE CATHETER REPORTEDLY PASSED SOME HEAVY CALCIFICATION AS IT WAS ADVANCED INTO THE SFA. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE CATHETER. WITHIN THE FIRST THIRTY MINUTES OF THE PROCEDURE, THE DECISION WAS MADE TO EXCHANGE THE WIRE FOR A HYDROPHILIC WIRE, TO CONTINUE FURTHER DOWN THE LIMB AND INTO THE POPLITEAL VESSEL. AS THE USER ATTEMPTED TO REMOVE THE WIRE FROM THE CATHETER, IT WOULD NOT COME BACK THROUGH THE CATHETER AND APPEARED TO BE STUCK; THEREFORE, THE USER CUT THE HUB OF THE CATHETER, AND THE WIRE WAS REMOVED. THE CATHETER DID NOT SEPARATE. PER THE USER, THE WIRE WAS INTACT UPON REMOVAL. THE WIRE WAS NOT ALTERED PRIOR TO USE. ANOTHER CXI CATHETER AND 0.018-INCH WIRE WERE USED TO REACH THE TARGET LESION AND SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864480 ↗
• MalfunctionFeb 10, 2022Material Separation; Material Separation

  AS REPORTED, DURING A VASCULAR ANGIOGRAM AND STENT PLACEMENT, A CXI SUPPORT CATHETER WAS PLACED VIA FEMORAL ACCESS OVER ANOTHER MANUFACTURERS GUIDE WIRE BUT WAS UNABLE TO BE ADVANCED PAST "3 TO 5 CENTIMETERS." THE WIRE AND CXI WERE REMOVED AND A PIECE WAS SHEARED OFF. IT IS UNKNOWN IF THE SHEARED PIECE IS FROM THE COOK CATHETER OR THE OTHER MANUFACTURER'S GUIDE WIRE. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505380 ↗
• InjuryMar 1, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11391922 ↗
• MalfunctionMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER HUB SEPARATED FROM THE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774607 ↗
• MalfunctionDec 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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 8170124 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE HUB BECAME DETACHED FROM THE SHAFT OF THE CXI SUPPORT CATHETER DURING A TIBIAL PERONEAL TRUNK INTERVENTION PROCEDURE. THIS OCCURRED WHILE TRYING TO CROSS A TIGHT, "VERY" CALCIFIC LESION WHILE TORQUING THE CATHETER. A SECOND CXI SUPPORT CATHETER WAS USED WHICH ALSO COULD NOT CROSS THE LESION BUT NO HUB DETACHMENT WAS REPORTED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING ANOTHER MANUFACTURER'S 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 Known Impact Or Consequence To Patient

  MAUDE report 7865328 ↗
• MalfunctionJan 18, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION FOR RECANALIZATION, THE CXI SUPPORT CATHETER STRAIN RELIEF HUB SNAPPED OFF AS THE CATHETER WAS BEING REMOVED. IT WAS NOTED THAT THE PHYSICIAN PULLED THE CATHETER BY THE HUB DURING REMOVAL. CONTRALATERAL ACCESS TO THE PATIENT'S COMMON FEMORAL ARTERY WAS GAINED BY CROSSING OVER THE AORTOILIAC BIFURCATION UTILIZING A SHEATH. THE PATIENT'S VESSEL WAS NOTED TO BE CALCIFIED. ANOTHER CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203157 ↗
• MalfunctionNov 2, 2017Stretched; Material Twisted/Bent

  THE PHYSICIAN USED A CXI CATHETER AND THE BODY OF THE CATHETER BECAME TWISTED AND STRETCHED. THE CATHETER WAS REMOVED AND ANOTHER DEVICE USED. 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 6995751 ↗
• MalfunctionNov 1, 2017Kinked; Leak/Splash; Failure to Advance; Positioning Problem

  AS REPORTED TO CUSTOMER RELATIONS, INITIALLY, THE DOCTOR WAS ABLE TO PASS A WIRE ALL THE WAY THROUGH THE CATHETER. AT THIS POINT THE WIRE WAS REMOVED AND A SHOT OF CONTRAST WAS INJECTED THRU THE CATHETER. THE PHYSICIAN WENT TO PUT THE WIRE (G52543) BACK THRU THE CATHETER IT WOULD NOT PASS THRU. THERE WAS NO KINK VISIBLE AND THE ACT WAS ABOVE 300. THEY USED A PILOT 150 WIRE AND THE CONTRAST USED WAS OMNIPAQUE 300. EVERYTHING WAS REMOVED AND THEY WERE ABLE TO PASS THE STENOSIS WITH THE G52543; HOWEVER ONCE THEY WERE PASSED THE STENOSIS THEY WERE NOT ABLE TO ADVANCE THE WIRE ANY FURTHER BECAUSE THERE WAS A KINK IN THE CATHETER. THIS KINK IS RIGHT WHERE ONE OF THE BLACK BANDS IS ON THE CATHETER. THIS DEVICE WAS PULLED OUT OF THE BODY AND OBSERVED BY THE PHYSICIAN. IT WAS KINKED SO BAD THAT THE BRAIDING WAS EXPOSED. THE TWO ABOVE DEVICES WERE UTILIZED THRU THE ACCESS POINT OF THE LEFT RADIAL ARTERY. THE PHYSICIAN WAS USING A G56232 IN THE RIGHT COMMON FEMORAL AND THE VALVE LEAKED THRU THE ENTIRE CASE. THIS SHEATH WAS USED UNTIL THE PROCEDURE WAS COMPLETED AS THIS WAS A SLOW LEAK. THERE WERE NO ADDITIONAL PROCEDURES; NO ADVERSE EFFECTS REPORTED AND NO DEVICE BREAKAGE OR SEPARATION REPORT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6992699 ↗
• MalfunctionOct 31, 2017Detachment Of Device Component

  CXI CATHETER WAS USED TO CROSS A DISTAL POPLITEAL LESION. AS THE PHYSICIAN WAS TORQUING THE HUB OF THE CATHETER, THE HUB DETACHED. THE CATHETER WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AND 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 6991738 ↗
• MalfunctionOct 30, 2017Failure to Advance; Material Twisted/Bent

  THE CXI SUPPORT CATHETER WAS USED FOR A LEFT LEG ARTERIOGRAM INTERVENTION. THE CATHETER WAS OVER A WIRE GUIDE, SUBINTIMAL, AND USED TO CROSS A VERY TIGHT LONG LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DOCTOR TRIED TO ROTATE THE CATHETER MULTIPLE TIMES TO REDIRECT THE TIP, CAUSING THE MIDDLE OF THE CATHETER TO TWIST TO THE POINT WHERE THE CATHETER WOULD NO LONGER ADVANCE OVER THE WIRE GUIDE. THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. DEVICE IMAGING IDENTIFIED TWISTING IN THE CATHETER TO THE POINT OF COMPROMISE IN MATERIAL INTEGRITY.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 6987201 ↗
• MalfunctionAug 14, 2017Material Separation; Material Separation

  A CXI SUPPORT CATHETER WAS USED IN AN 'UP & OVER RIGHT LEG ANGIOPLASTY & WOULD DEBRIDEMENT" PROCEDURE. IT WAS REPORTED THAT THE DEVICE SNAPPED OFF WHILE TRAVELING THROUGH STENOSIS. 15CM OF CXI WAS LEFT INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND, ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6791815 ↗
• InjuryDec 1, 2016Material Separation; Appropriate Device Problem Term/Code Not Available; Material Separation; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO CUSTOMER RELATIONS: "WHILE TRYING TO CANULATE THE RIGHT RENAL AND GAIN ACCESS, THE TIP OF THE CATHETER BROKE AND REMAINED IN THE RIGHT RENAL ARTERY. IT NEVER GOT RETRIEVED. THE PHYSICIAN PUT A PLUG IN THE RIGHT FENESTRATION TO BLOCK THE RIGHT RENAL BECAUSE OF ENDOLEAK CREATED WITH THE FACT THAT THE RIGHT RENAL WAS NOT LEFT PATENT. PATIENT WILL LOOSE HER RIGHT." ADDITIONAL INFORMATION WAS REQUESTED FOR THE CUSTOMER.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6137617 ↗