CXI G52542Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002525429), received between Jul 11, 2018 and Feb 27, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Break

  AS REPORTED, DURING A PROCEDURE INVOLVING ARTERIAL RECANALIZATION FOR AN OCCLUSION OF THE LEFT LOWER EXTREMITY, A CXI SUPPORT CATHETER SEPARATED. UNDER FLUOROSCOPIC GUIDANCE, ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY FOR A CONTRALATERAL APPROACH TO THE LEFT LOWER EXTREMITY. THE ANATOMY WAS REPORTEDLY CALCIFIED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED AS THE USER ATTEMPTED TO ADVANCE AN UNSPECIFIED STANDARD WIRE GUIDE OVER THE BIFURCATION TO THE LEFT LOWER EXTREMITY, MAKING ADVANCEMENT DIFFICULT. THE USER THEN ATTEMPTED TO USE THE CXI CATHETER FOR RECANALIZATION; HOWEVER, REPEATED ATTEMPTS TO ADVANCE THE CATHETER WERE UNSUCCESSFUL. ANOTHER MANUFACTURER¿S BALLOON CATHETER WAS THEN USED TO ATTEMPT PRE-DILATION OF THE VESSEL. UPON ATTEMPTED ADVANCEMENT OF THE BALLOON, ANGIOGRAPHY REVEALED THAT THE WIRE GUIDE WAS NOT ADVANCING, AS A SECTION OF THE CXI CATHETER HAD SEPARATED IN THE VESSEL. THE SEPARATED FRAGMENT WAS REMOVED WITH A BASKET WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470313 ↗
• MalfunctionDec 4, 2025Difficult to Remove; Difficult to Remove

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

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

  MAUDE report 23715245 ↗
• MalfunctionMay 28, 2025Material Perforation; Material Perforation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, ANOTHER MANUFACTURER'S WIRE GUIDE WENT THROUGH A CXI SUPPORT CATHETER. THE PATIENT'S ANATOMY WAS CALCIFIED, TORTUOUS AND STENOSED. BOTH A STIFF AND STANDARD WIRE GUIDE WERE USED DURING THE PROCEDURE. WHILE TRYING TO CROSS THE OCCLUSION, THE CXI WAS ADVANCED AHEAD OF THE WIRE AND KINKED. THE WIRE ALSO WENT THROUGH THE SIDE OF THE CATHETER. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH A NEW CATHETER. IT IS UNKNOWN IF RESISTANCE WAS FELT DURING INSERTION AND/OR ADVANCEMENT OF THE CATHETER, HOWEVER, THERE WAS DIFFICULTY ADVANCING UNSPECIFIED SHEATH UP AND OVER THE BIFURCATION DUE TO THE TORTUOSITY. THERE WAS NO HARM TO THE PATIENT. 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 OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095443 ↗
• MalfunctionOct 7, 2022Material Puncture/Hole; Material Puncture/Hole

  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 15563893 ↗
• MalfunctionJun 2, 2022Material Perforation; Material Perforation

  AS REPORTED, A CXI SUPPORT CATHETER WAS USED TO DEPLOY A NESTER EMBOLIZATION DEVICE, AGAINST THE ADVICE OF A COMPANY REPRESENTATIVE. THE COIL BECAME STUCK IN THE CXI, AND AS AN UNSPECIFIED WIRE WAS USED TO PUSH THE COIL OUT, THE WIRE PERFORATED THE CATHETER, MAKING A HOLE IN THE DEVICE THAT THE WIRE CAME THROUGH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14575151 ↗
• MalfunctionApr 28, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING INSPECTION OF THE DEVICE, A HAIR WAS OBSERVED WITHIN THE UNOPENED PACKAGING OF A CXI SUPPORT CATHETER. THE DEVICE WAS NOT USED FOR A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237179 ↗
• InjuryMay 18, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 27SEP2021. THE TARGET LESION WAS IN THE LEFT ILIAC VEIN. THE PATIENT'S ANATOMY WAS FIBROTIC AND TORTUOUS. THE DEVICE SEPARATED DURING REMOVAL FROM THE PATIENT BEFORE INTRODUCTION OF A BALLOON.

  Patient problems: Foreign Body In Patient

  MAUDE report 11842844 ↗
• MalfunctionOct 3, 2019Fluid/Blood Leak; Deformation Due to Compressive Stress; Fluid/Blood Leak; Deformation Due to Compressive Stress

  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 9151249 ↗
• MalfunctionMay 24, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  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 8640866 ↗
• InjuryOct 3, 2018Material Separation; Material Separation

  IT WAS REPORTED AN (B)(6) MALE PATIENT WITH UNKNOWN PAST MEDICAL HISTORY WAS UNDERGOING A LOWER EXTREMITY ANGIOPLASTY PROCEDURE. ACCESS WAS GAINED VIA THE BRACHIAL ARTERY. WHILE ATTEMPTING TO ADVANCE THE CXI SUPPORT CATHETER OVER THE TORTUOUS BIFURCATION, RESISTANCE WAS FELT MAKING IT IMPOSSIBLE TO ADVANCE FURTHER. IT WAS ADDITIONALLY REPORTED, THE PHYSICIAN WAS TWISTING THE COMPLAINT CXI SUPPORT CATHETER AND USING A BIT OF FORCE, SHOVING THE DEVICE. THE DEVICE BUCKLED AND WAS DIFFICULT TO REMOVE OVER A 0.35 INCH GLIDE WIRE. UPON REMOVAL OF THE COMPLAINT DEVICE FROM THE PATIENT'S ANATOMY, IT WAS NOTED APPROXIMATELY 15 CM HAD DETACHED IN THE PATIENT. A SNARE WAS USED TO REMOVE THE SEPARATED PORTION FROM THE BRACHIAL ARTERY ACCESS. THE ANGIOPLASTY PROCEDURE WAS ABORTED AND RESCHEDULED BUT CANCELLED BECAUSE THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT WITH ANEURYSMAL COMPLICATIONS IN THE BRACHIAL ARTERY.ALTHOUGH REQUESTED, NO INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT OUTCOME OR IF THE ORIGINAL PROCEDURE WAS RESCHEDULED.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 7931332 ↗
• MalfunctionJul 11, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED, THE CXI SUPPORT CATHETER WAS BEING UTILIZED FOR A PROCEDURE TO OPEN AN OCCLUSION IN THE PATIENT'S FEMORAL ARTERY VIA IPSALATERAL APPROACH. WHILE ADVANCING THE CXI SUPPORT CATHETER ALONG THE WIRE GUIDE, IT BECAME LODGED AND WOULD NOT ADVANCE. UPON REMOVAL, THE MIDDLE SECTION WAS FOUND TO BE COMPRESSED. BECAUSE ONLY ONE CXI SUPPORT CATHETER HAD BEEN PREPARED, THE PROCEDURE COULD NOT BE COMPLETED. IT IS NOT KNOWN WHEN IT WILL BE RESCHEDULED. DURING FOLLOW UP WITH THE COMPLAINANT, IT WAS REPORTED THE COMPLAINT DEVICE HAD BEEN FLUSHED PRIOR TO PLACEMENT IN THE VESSEL. THE DEVICE FLUSHED NORMALLY; THE COMPRESSED SECTION WAS NOT OBSERVED. THE PATIENT'S ANATOMY PRESENTED WITH TORTUOSITY AND CALCIFICATION WITH AN ARTERY OCCLUSION OF 0.5 CENTIMETERS. THE PATIENT OUTCOME HAS BEEN REPORTED AS "NORMAL". 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 7678190 ↗