CXI G52545Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002525450), received between May 2, 2016 and Aug 11, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2023Break; Break

  AS ORIGINALLY REPORTED, DURING AN ENDOVASCULAR TREATMENT PROCEDURE, A CXI SUPPORT CATHETER'S HUB SEPARATED. THE DEVICE PACKAGE WAS NOT DAMAGED. ANOTHER MANUFACTURER'S 45-CENTIMETER SHEATH WAS USED DURING THE PROCEDURE. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET A THIRTY-CENTIMETER, CALCIFIED, CHRONIC TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS REPORTEDLY CALCIFIED, BEGINNING AT THE ACCESS SITE, AND THE AORTIC BIFURCATION WAS TIGHT. AFTER ANOTHER MANUFACTURER'S WIRE GUIDE WAS PASSED, THE HUB OF THE CATHETER BROKE, REPORTEDLY DUE TO THE CALCIFIED LESION. PER THE REPORTER, RESISTANCE WAS NOT ENCOUNTERED UPON ADVANCEMENT OF THE WIRE OR THE CATHETER. ANOTHER MANUFACTURER'S DEVICE WAS USED TO CROSS THE LESION AND COMPLETE THE PROCEDURE. THE PHYSICIAN COMMENTED THAT THE CXI WAS "OVERLOADED" DUE TO THE HIGHLY CALCIFIED LESION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND EVALUATION OF THE DEVICE ON (B)(6) 2023, THE CATHETER MATERIAL WAS SEPARATED AT THE LEVEL OF THE HUB, WITH CATHETER MATERIAL REMAINING INSIDE THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514493 ↗
• MalfunctionDec 1, 2021Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909036 ↗
• MalfunctionApr 7, 2021Material Frayed; Failure to Advance; Material Frayed; Failure to Advance

  AS REPORTED, DURING AN EVT A CXI SUPPORT CATHETER STOPPED ADVANCE AND WAS REMOVED WHEN IT WAS FOUND TO BE FRAYED. A CONTRALATERAL APPROACH WAS GAINED FROM THE LEFT FEMORAL ARTERY TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE BELOW-KNEE REGION, INCLUDING THE SFA, WAS SEVERELY CALCIFIED. THE LESION WAS 90% OCCLUDED. THE CXI CATHETER WAS USED TO SUPPORT THE WIRE GUIDE, BUT THE CALCIFICATION WAS SEVERE AND THE CATHETER STOPPED ADVANCING AROUND THE POPLITEAL ARTERY. THE USER THEN REMOVED TO THE CXI AND FOUND THE TIP WAS FRAYED. THE USER THAN SWITCHED FROM A 0.035 SYSTEM TO A 0.018 SYSTEM INSTEAD. A POBA WAS THEN PERFORMED TO THE BELOW-KNEE REGION AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627031 ↗
• MalfunctionOct 10, 2018Stretched; Stretched

  IT WAS REPORTED, THE TIP OF THE CXI SUPPORT CATHETER EXPERIENCED ELONGATION OF THE DISTAL TIP. THE APPROACH WAS GAINED VIA THE LEFT ELBOW AS THE CONTRALATERAL AND IPSILATERAL APPROACHES WERE UNAVAILABLE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE THROUGH THE LESION, HOWEVER THE TIP OF THE DEVICE BECAME TRAPPED DUE TO SEVERE CALCIFICATION. AT THIS TIME, THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND NOTICED THE SLIGHTLY ELONGATED DISTAL TIP. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. THE CXI SUPPORT CATHETER WAS REPLACED WITH ANOTHER DEVICE AND THE APPROACH WAS GAINED FROM THE POSTERIOR TIBIAL ARTERY TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS. IT WAS STATED THAT THE PATIENT RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7954294 ↗
• MalfunctionSep 20, 2018Stretched; Stretched

  IT WAS REPORTED, A FEMALE PATIENT WITH A HISTORY OF PERIPHERAL ARTERY DISEASE UNDERWENT ENDOVASCULAR THERAPY (EVT) OF THE LEFT COMMON FEMORAL ARTERY (CFA) VIA CONTRALATERAL APPROACH FROM THE RIGHT CFA. UPON REMOVAL OF THE CXI SUPPORT CATHETER FROM THE PATIENT'S ANATOMY, THE TIP WAS NOTED TO BE ELONGATED. DURING INITIATION OF THE EVT PROCEDURE, ANOTHER MANUFACTURER'S GUIDING CATHETER WAS ADVANCED TO THE CONTRALATERAL SIDE FROM THE RIGHT CFA. THE PHYSICIAN ATTEMPTED TO MAKE THE COMBINATION OF A ANOTHER MANUFACTURERS' MICROCATHETER AND WIRE GUIDE RUN THROUGH A CHRONIC TOTAL OCCLUSION (CTO) WHICH EXISTED ON THE WAY TO THE TARGET LESION. HOWEVER, IT DID NOT CROSS THE CTO. THE WIRE GUIDE WAS EXCHANGED FOR ANOTHER, THE RESULT WAS THE SAME. THEREFORE, THE MICROCATHETER WAS CHANGED TO THE COMPLAINT CXI SUPPORT CATHETER ALONG WITH ANOTHER MANUFACTURER'S WIRE GUIDE. ATTEMPTS TO MAKE THE COMBINATION OF THE COMPLAINT DEVICE AND THE WIRE GUIDE PASS THROUGH THE CTO WAS CONDUCTED BY USING A KNUCKLE WIRE TECHNIQUE BUT, IT WAS FELT THE TIP OF THE COMPLAINT DEVICE WAS GETTING STUCK ON THE CTO DURING THAT ATTEMPT. THUS, IT WAS REMOVED OUT OF THE PATIENT'S ANATOMY AND THE TIP ELONGATION WAS NOTED. ANOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893077 ↗
• InjuryMay 2, 2016Material Separation; Material Separation

  THE CXI GOT SEPARATED AT 10CM FROM THE TIP INSIDE THE PATIENT. THE SEPARATED SEGMENT COULD BE RETRIEVED AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ON 28/ARP/2016, UPDATED INFORMATION IS PROVIDED AS BELOW; CONTRALATERAL APPROACH WAS MADE FROM THE RIGHT FA TO TREAT THE LEFT BK. A WIRE GUIDE COULD REACH TO THE LEFT LIMB THOUGH, ANOTHER MANUFACTURERS SHEATH WITH THE DILATOR SET INSIDE COULD NOT PASS ACROSS THE BIFURCATION AREA DUE TO CALCIFICATION AND TORTUOSITY OF THE VESSEL. ONLY THE DILATOR WAS REMOVED, THEN CXI WAS INSERTED INTO THE OTHER MANUFACTURERS SHEATH WHICH WAS HOOKED ON NEAR THE BIFURCATION. HOWEVER, THE USER ENCOUNTERED AN ADVANCEMENT DIFFICULTY BEYOND THE BIFURCATION, AND THE DIFFICULTY COULD NOT BE RESOLVED EVEN BY APPLYING TORQUE TO THE CXI. THEREFORE, THE USER REMOVED THE CXI, THEN NOTICED THAT THE DEVICE TIP, APPROXIMATELY 15CM IN LENGTH, WAS MISSING. THE SEPARATED SEGMENT WAS LEFT IN/NEAR THE LEFT CIA AND RETRIEVED WITH A SNARE DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 5624057 ↗