ELITECROSS Support Catheter MGC39090ARecalls & reported problems
Cordis US Corp. · Support Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032067482), received between May 10, 2022 and May 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
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
Device problems
- Crack1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2022Crack; Difficult to Remove; Crack; Difficult to Remove
AS REPORTED, THE DISTAL END OF THE AN 82CM ANGLED - EXTRA SUPPORT ELITECROSS SUPPORT CATHETER BECAME TRAPPED AT THE POINT OF TOTAL OCCLUSION AND WAS DIFFICULT TO REMOVE. ADDITIONALLY, AFTER REMOVAL OF THE ELITECROSS SUPPORT CATHETER, THERE WAS A CRACK OBSERVED AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN BALLOON CATHETER AND THE IMPLANTATION OF AN UNKNOWN STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED, CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) IN WHICH A CONTRALATERAL APPROACH WAS MADE WITH THE ELITECROSS SUPPORT CATHETER. THERE WAS NO TORTUOSITY TO THE TARGET VESSEL. THE ELITECROSS SUPPORT CATHETER WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY. THE DEVICE DID NOT KINK DURING THE PROCEDURE AND REMAINED IN ONE PIECE DURING REMOVAL. IT WAS REPORTED THAT A NON-CORDIS GUIDEWIRE WAS ABLE TO CROSS THE LESION, THERE WAS NO DAMAGE TO THE GUIDEWIRE, AND IT WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. IT WAS MENTIONED BY THE PHYSICIAN THAT THE USE OF EXCESSIVE FORCE IN THE VICINITY OF SEVERE CALCIFICATION COULD HAVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14347739 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.