CXI G50004Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002500044), received between Jul 31, 2017 and Nov 5, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 5, 2024Break; Break

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE OF THE RIGHT LOWER LEG, A CXI SUPPORT CATHETER'S TIP WAS BROKEN OFF. THE BROKEN TIP WAS NOTED UPON OPENING THE PRODUCT PACKAGING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614144 ↗
• MalfunctionJul 7, 2022Break; Break

  AS REPORTED, A CXI SUPPORT CATHETER FRACTURED DURING A PROCEDURE INVOLVING INFUSION OF A CHEMOTHERAPY DRUG VIA A "PUMPING MACHINE." AN UNSPECIFIED SHEATH, CATHETER, AND WIRE WERE ALSO USED DURING THE PROCEDURE. 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. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945489 ↗
• MalfunctionAug 2, 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 8854829 ↗
• MalfunctionJun 20, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2019 NOTING THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. BOTH AN ANSEL SHEATH AND "V18" WIRE WERE ALSO UTILIZED IN THE PROCEDURE. REPORTEDLY, THE PATIENT'S ANATOMY PRESENTED WITH CALCIFICATION WITH RESISTANCE NOTED BOTH ON INSERTION AND REMOVAL DESPITE THE HYDROPHILIC COATING HAVING BEEN ACTIVATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715891 ↗
• InjuryApr 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 Code Available

  MAUDE report 8529172 ↗
• MalfunctionNov 28, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED FOREIGN MATTER, DESCRIBED AS "SOMETHING LIKE DUST," WAS CONFIRMED INSIDE THE UNOPENED CXI SUPPORT CATHETER PACKAGE. THE DEVICE NEVER MADE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8109980 ↗
• MalfunctionJul 16, 2018Material 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 Known Impact Or Consequence To Patient

  MAUDE report 7689905 ↗
• InjuryMay 7, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE CXI SUPPORT CATHETER BROKE AT THE TIP DURING A PERCUTANEOUS NEPHROURETERAL STENT PLACEMENT AND WAS RETAINED IN THE PATIENT'S KIDNEY. THE PHYSICIAN WAS ATTEMPTING TO MANIPULATE THE CATHETER PAST A KIDNEY STONE WHEN THE EVENT OCCURRED. SINCE THE PATIENT WAS SCHEDULED FOR A SURGICAL PROCEDURE (PERCUTANEOUS NEPHROLITHOTOMY, LEFT URETEROSCOPY, LASER LITHOTRIPSY, AND STONE EXTRACTION) THE BROKEN PORTION OF THE CXI SUPPORT CATHETER WAS ABLE TO BE SUCCESSFULLY REMOVED DURING THIS PROCEDURAL TIME. ACCORDING TO THE INITIAL REPORTER, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7492093 ↗
• MalfunctionNov 2, 2017Material Perforation

  DURING THE PERIPHERAL ARTERIAL OCCLUSIVE DISEASE PROCEDURE ON THE (B)(6) MALE PATIENT, THE CHRONIC TOTAL OCCLUSION WIRE PERFORATED THE DEVICE WHILE DEVICES WENT THROUGH THE ANTERIOR TIBIAL ARTERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6996544 ↗
• MalfunctionNov 1, 2017Break; Entrapment of Device; Unraveled Material

  IT WAS REPORTED THAT THE DEVICE COULD PASS THROUGH THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE CXI, THE DEVICE GOT CAUGHT INSIDE OF THE SHEATH. IT WAS CONFIRMED THAT THE TIP OF THE CXI GOT DAMAGED AS THE COIL AT TIP OF THE CXI WAS UNRAVELED. ANOTHER CXI WAS USED TO COMPLETE THE PROCEDURE. 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 6993422 ↗
• MalfunctionNov 1, 2017Stretched

  IT WAS REPORTED THAT WHILE REMOVING THE CATHETER IT BECAME ELONGATED. THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION OF THE LEFT COMMON ILIAC ARTERY, APPROACH WAS IPSILATERAL RETROGRADE. THE DEVICE WAS ADVANCED, WITH ANOTHER MANUFACTURE'S WIRE GUIDE AND IT WAS TRAPPED BY THE CALCIFIED PART OF THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE CATHETER, IT BECAME ELONGATED/ DAMAGED. THE USER REPLACED THE DEVICE WITH ANOTHER ONE TO CONTINUE THE PROCEDURE THOUGH; THE REPLACEMENT WOULD NOT PASS THROUGH THE DISTAL SITE OF THE CTO, SO THE PROCEDURE ENDED UNSUCCESSFULLY WITH NO FURTHER TREATMENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6992667 ↗
• MalfunctionOct 31, 2017Physical Resistance; Positioning Problem

  DURING TABLE TOP TESTING AND PRIOR TO PATIENT CONTACT, THE CXI SUPPORT CATHETER WOULD NOT ACCEPT THE GUIDEWIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A WIRE WAS INSERTED INTO THE RETURNED DEVICE WITH SOME RESISTANCE AND A UNKNOWN BLACK MATERIAL EXITED THE DISTAL TIP. 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 6989841 ↗
• InjuryJul 31, 2017Material Separation; Material Separation

  IT HAS BEEN ALLEGED THAT A CXI SUPPORT CATHETER WAS BEING USED DURING AN ILIAC STENTING PROCEDURE WHEN IT SEPARATED. THE COMPLAINANT REPORTS THAT THE PATIENT PRESENTED WITH A HIGHLY CALCIFIED ILIAC OCCLUSION, AND THE CATHETER WOULD NOT PASS THE COMPLETELY THROUGH. ALLEGEDLY , AS THE CATHETER WAS PARTIALLY ADVANCED THROUGH THE OCCLUSION, THE PHYSICIAN BEGAN TO PULL IT BACK BUT FELT RESISTANCE. AS THE PHYSICIAN CONTINUED TO PULL ON THE CATHETER, IT SEPARATED. THE REMAINING SECTION OF THE CATHETER WAS RETRIEVED VIA SNARE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6755456 ↗