ELITECROSS Support Catheter MGC39140XRecalls & reported problems
Cordis US Corp. · Support Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032067536), received between Jul 8, 2024 and Nov 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Stretched1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING DEEP VEIN LAST WEEK, WHILE USING ONE OF THE 132CM ELITECROSS EXTRA SUPPORT CATHETER, THE WHITE END PIECE ENDING UP BREAKING OFF AFTER ONE USE. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE USER WAS TRAINED IN USING THE DEVICE. THE DEVICE WAS STORED AND OPENED IN A STERILE FIELD. THE DEVICE WAS USED IN THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20797316 ↗MalfunctionJul 8, 2024Stretched; Unraveled Material; Detachment of Device or Device Component; Stretched; Unraveled Material; Detachment of Device or Device Component
AS REPORTED, THE PHYSICIAN USED TWO (2) ELITECROSS 132CM EXTRA SUPPORT CATHETERS ON A PATIENT ALONG WITH AN UNKNOWN HYDROPHILIC WIRE TO ADVANCE THE ELITECROSS PROXIMAL TO A STENTED PORTION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). UPON ADVANCEMENT OF THE FIRST ELITECROSS OVER THE WIRE, IT WAS NOTICED THAT THE CATHETER WAS UNRAVELING. THE PHYSICIAN THEN PROCEEDED TO PULL A SECOND ELITECROSS CATHETER AND ADVANCED IT OVER A HYDROPHILIC WIRE DISTAL TO THE STENTED PORTION IN THE PATIENT¿S SFA AND NOTICED THAT THIS ELITECROSS WAS ALSO UNRAVELING, AND A PORTION OF THE CATHETER HAD BROKEN OFF AND WAS LEFT IN THE ARTERY. THE PHYSICIAN REPORTED USING A .035 NON-CORDIS SUPPORT CATHETER TO RECAPTURE THE PIECE OF THE ELITECROSS THAT WAS BROKEN OFF IN THE ARTERY. THE RECOVERED PIECE IS INCLUDED IN THE COMPLAINT BAG. THE HOSPITAL IS UNABLE TO CONFIRM THE LOT NUMBER FOR EITHER ONE OF THESE ELITECROSS CATHETERS. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19697625 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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