CXI G52546Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002525467), received between May 4, 2016 and Mar 11, 2025 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE INVOLVING A RENAL ANGIOGRAM WITH STENT PLACEMENT, A CXI SUPPORT CATHETER TWISTED AS THE USER TORQUED THE DEVICE WITHIN A TIGHT LESION IN THE RIGHT RENAL ARTERY. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. AS THE USER ATTEMPTED TO CROSS THE LESION BY TORQUING THE CATHETER, IT "TWISTED UP ON ITSELF". ANOTHER CATHETER WAS USED TO CROSS THE LESION AND CONTINUE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND EVALUATION OF THE DEVICE, THE CATHETER WAS TWISTED, WITH THE INNER WIRES EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577481 ↗
• MalfunctionFeb 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SPLIT. ANOTHER MANUFACTURER¿S 6-FRENCH SHEATH WAS USED TO OBTAIN ACCESS IN THE RIGHT COMMON FEMORAL ARTERY, AND AN IPSILATERAL, ANTEGRADE APPROACH WAS USED TO TARGET A CHRONIC, TOTALLY OCCLUDED LESION IN THE RIGHT SHALLOW FEMORAL ARTERY. THE LESION WAS OVER TWENTY CENTIMETERS IN LENGTH AND SEVERELY CALCIFIED. ANOTHER MANUFACTURER¿S 0.035-INCH WIRE PASSED THROUGH THE LESION. THE USER THEN ATTEMPTED TO ¿BREAK THROUGH¿ THE LESION BY ADVANCING THE CXI OVER THE WIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE CATHETER STOPPED APPROXIMATELY HALF-WAY THROUGH THE LESION. PER THE REPORTER, UPON ENCOUNTERING RESISTANCE, THE USER REPEATEDLY PUSHED AND PULLED THE CATHETER. UPON REMOVAL OF THE DEVICE, THE USER NOTED THAT THE TIP OF THE CATHETER HAD SPLIT. THE CATHETER WAS EXCHANGED FOR ANOTHER MANUFACTURER¿S 4-FRENCH CATHETER, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTEDLY STATED THAT THE CXI MAY HAVE BEEN PUSHED TOO FAR, DUE TO SEVERE CALCIFICATION WITHIN THE CHRONIC TOTAL OCCLUSION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421943 ↗
• InjuryAug 26, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT AND STENT PLACEMENT WITHIN A SUB-RENAL AORTIC ANEURYSM VIA ACCESS IN THE FEMORAL ARTERY, A CXI SUPPORT CATHETER SEPARATED. THE CATHETER REPORTEDLY SEPARATED IN THE RIGHT RENAL ARTERY, BEFORE THE STENT WAS INSERTED. THE SEPARATED FRAGMENT, WHICH WAS VISIBLE UNDER X-RAY, WAS REPORTEDLY "IMPOSSIBLE TO RETRIEVE". PER THE REPORTER, TWO-TO-TEN CENTIMETERS OF THE CATHETER REMAINS IN THE PATIENT, WITH A RISK OF OCCLUDING A RIGHT RENAL COLLATERAL ARTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20070392 ↗
• MalfunctionAug 22, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 07SEP2023. THE PROCEDURE WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT. ANOTHER MANUFACTURER'S WIRE GUIDE WAS USED DURING THE PROCEDURE. THE ACCESS SITE WAS NOT SCARRED. THE ANATOMY WAS CALCIFIED; HOWEVER, IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OR REMOVAL OF THE CATHETER. A POWER INJECTOR WAS NOT USED. AT THE BEGINNING OF CLOSURE, THE PHYSICIAN ATTEMPTED TO CROSS FROM THE LEFT ILIAC ARTERY TO THE RIGHT ILIAC ARTERY. AS THE DEVICE TURNED INTO THE RIGHT ILIAC ARTERY, THE CATHETER SEPARATED. THE INITIAL ATTEMPT TO REMOVE THE DEVICE WITH A SNARE WAS UNSUCCESSFUL, SO THE PHYSICIAN GAINED ACCESS IN THE RIGHT DISTAL FEMORAL ARTERY, MOVED THE BROKEN CATHETER FRAGMENT TO THE LEFT ILIAC ARTERY, AND THE FRAGMENT WAS REMOVED OUT OF THE LEFT FEMORAL ACCESS SITE, USING THE SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599339 ↗
• MalfunctionJan 11, 2023Break; 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 16141885 ↗
• InjurySep 2, 2022Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND AN IPSILATERAL APPROACH WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE ILIAC ARTERY. A 6 FRENCH SHEATH WAS USED FOR ACCESS. THE COMPLAINT DEVICE WOULD NOT ADVANCE THROUGH THE LESION AND WAS THEREFORE REMOVED. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, IT WAS NOTED TO BE KINKED AND SEPARATED APPROXIMATELY FIFTEEN CENTIMETERS FROM THE DISTAL END OF THE DEVICE. THE SEPARATED FRAGMENT OF THE DEVICE REMAINED IN THE ILIAC ARTERY. A BALLOON CATHETER WAS THEN ADVANCED TO THE DISTAL SIDE OF THE SEPARATED CXI FRAGMENT AND THE BALLOON WAS INFLATED, ALLOWING THE SEPARATED FRAGMENT TO BE PULLED WITH THE INFLATED BALLOON AND REMOVED FROM THE PATIENT. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15352233 ↗
• InjurySep 22, 2021Break; Material Separation; Break; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021: THE ACCESS SITE WAS THE POPLITEAL ARTERY, AND THE TARGET LOCATION WAS THE NATIVE SUPERIOR FEMORAL ARTERY. THE DEVICE WAS RETRIEVED USING A SNARE. THE ISSUE DID NO LEAD TO ANY ADDITIONAL PROCEDURES BEING REQUIRED. THE PATIENT'S ANATOMY WAS NOT NOTED TO BE TORTUOUS OR CALCIFIED. THE SEPARATION WAS NOTED TO OCCUR "PAST THE TIP ABOUT TO THE 2ND DUROMETER ZONE". THE PATIENT'S OUTCOME WAS NOTED TO BE "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513877 ↗
• InjuryMar 26, 2021Material Separation; Material Separation

  AS REPORTED, DURING A PERIPHERAL VASCULAR PROCEDURE TARGETING THE PERITIBIAL TRUNK, A CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND AN UNSPECIFIED 6 FRENCH SHEATH AND ANOTHER MANUFACTURER'S WIRE GUIDE WERE IN PLACE. TWO KISSING STENTS WERE LOCATED AT THE BIFURCATION. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE HYDROPHILIC COATING WAS ACTIVATED PRIOR TO USE AND THE DEVICE FITTING WAS WIPED WITH SALINE. DURING MANIPULATION OF THE CATHETER UP AND OVER THE BIFURCATION, WITH THE WIRE IN PLACE, THE CATHETER RUBBED AGAINST ONE OF THE PREVIOUSLY-PLACED STENTS AND SEPARATED INTO TWO SECTIONS, AT APPROXIMATELY FIFTEEN CENTIMETERS FROM THE PROXIMAL END. RESISTANCE WAS NOT REPORTED. THE PROXIMAL PORTION OF THE DEVICE WAS REMOVED MANUALLY. THE DISTAL SECTION WAS ON THE WIRE GUIDE AND WAS POINTING UP INTO THE AORTA. THE USER ADVANCED AN UNKNOWN SNARE OVER THE WIRE GUIDE AND CAPTURED THE DISTAL PORTION OF THE CATHETER, REMOVING THE DEVICE FROM THE PATIENT. THE CASE WAS ULTIMATELY ABORTED BECAUSE THE USER THOUGHT THAT THE KISSING STENTS WERE TOO MUCH OF AN OBSTACLE. THE PATIENT WILL RETURN FOR TREATMENT VIA A DIFFERENT ACCESS POINT AT A LATER DATE. A SECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574007 ↗
• InjuryAug 21, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER SEPARATED IN THE PATIENT. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED WITH AN UNKNOWN SNARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 10438442 ↗
• MalfunctionJul 8, 2019Material 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 8768924 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis

  MAUDE report 8598098 ↗
• InjurySep 19, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  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. THIS REPORT CAPTURES THE ABORTED PROCEDURE. PLEASE REFERENCE ALSO 1820334-2018-02607 WHICH CAPTURES SHARP EDGES ON THE CROSSCATH SUPPORT CATHETER.

  Patient problems: No Code Available

  MAUDE report 7889956 ↗
• MalfunctionJul 20, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED, THE CXI SUPPORT CATHETER EXPERIENCED DIFFICULT ADVANCEMENT DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY PROCEDURE. THE DEVICE WAS INSERTED FROM THE LEFT GROIN AND ADVANCED TO THE CALCIFIED LESION. WHILE THE WIRE GUIDE COULD PASS THROUGH "90% STENOSED SITE", THE CXI SUPPORT CATHETER WAS UNABLE TO ADVANCE FURTHER. ONCE RESISTANCE WAS FELT, THE PHYSICIAN REMOVED THE DEVICE TO EXAM IT, CONFIRMING THE TIP OF THE DEVICE WAS DAMAGED, "CURLED UP". AT THIS TIME, THE PROCEDURE WAS DISCONTINUED. A BYPASS OPERATION WAS PLANNED FOR A LATER DATE DUE TO THIS CANCELLED PROCEDURE. HOWEVER, THE DATE OF THE NEW OPERATION IS NOT KNOWN AS OF (B)(6) 2018. 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 Code Available

  MAUDE report 7707334 ↗
• InjuryOct 16, 2017Material Separation; Material Separation

  A CXI SUPPORT CATHETER WAS USED IN A RE-DO BY-PASS WITH GRAFT/RIGHT ILIAC SEATING. IT WAS REPORTED THAT THE TIP OF THE CATHETER FULLY SEPARATED DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TIP WAS RETRIEVED SEPARATELY FROM THE CATHETER, THE ENTIRE COMPONENT WAS REMOVED WITHOUT ANY HARM. 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; No Code Available

  MAUDE report 6953556 ↗
• InjuryMay 4, 2016Material Separation; Material Separation

  DURING AN ANGIOPLASTY FOR AT ARTERY PROCEDURE, THE PHYSICIAN ACCESSED FROM THE DP ARTERY. DID NOT USE AN INTRODUCER SHEATH BUT HAD THE BARE UNIGLIDE WIRE AND CROSSED CTO RETROGRADE. THE PATIENT HAD AN OCCLUSION IN THE AT ARTERY UP TO THE PAPATILE. THE UNIGLIDE WAS LOCKED IN AND CXI CATHETER ACROSS THE OCCLUSION. THE PHYSICIAN WANTED TO EXCHANGE THE CATHETER AND WHILE REMOVING FELT NO RESISTANCE. WHEN THE CATHETER WAS REMOVED IT WAS NOTED THAT APPROXIMATELY 15CM OF THE CATHETER HAD SEPARATED AND REMAINED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE WITH A SNARE BUT WAS UNSUCCESSFUL. DUE TO THE OCCLUSION AND THE DIFFICULTY OF REMOVAL THE PHYSICIAN LEFT THE FRAGMENT. NO FURTHER PROCEDURES ARE PLANNED AND THE PATIENT WAS DOING WELL AND RELEASED TO GO HOME. ADDITIONAL INFORMATION PROVIDED BY THE REP STATES: AFTER REMOVING THE CATHETER FROM THE PATIENT, THE PHYSICIAN CUT OFF A PORTION (DISTAL 5 CM) OF THE CATHETER WITH SCISSORS THINKING THAT HE WOULD PUT IT INTO THE PATIENT AGAIN WITH A CLEAN CUT. HE ULTIMATELY DID NOT PUT THE CATHETER BACK INTO THE PATIENT. THE PIECE THAT BROKE OFF DURING THE PROCEDURE REMAINED INSIDE THE PATIENT'S BODY. IT WAS THE PHYSICIAN'S DECISION TO LEAVE T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5630139 ↗