ELITECROSS Support Catheter MGC39090XRecalls & reported problems
Cordis US Corp. · Support Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 20705032067505), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2020Retraction Problem; Retraction Problem
AS REPORTED, THE 82CM ELITECROSS EXTRA SUPPORT WAS INSERTED TO THE PATIENT BUT IT WAS NOT ABLE TO CROSS THE LESION THEREFORE, IT WAS REMOVED AND NOTED THAT IT WAS FRAYED AT THE DISTAL END. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO VISIBLE DAMAGE NOTED TO THE DEVICE PRIOR TO OPENING THE PACKAGING. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE LESION WAS THE ILIAC ARTERY. THE TARGET VESSEL WAS SEVERE CALCIFIED, HAD LITTLE VESSEL TORTUOSITY, 90 PERCENT STENOSIS, HAD A LITTLE ACUTE ANGLE AND A LITTLE BIFURCATING. THE ACCESS SITE WAS THE FEMORAL ARTERY. THEY USED A CONTRALATERAL APPROACH USED. THE ACCESSING TARGET SITE WAS LITTLE CALCIFIED, HAD LITTLE TORTUOSITY, LOW PERCENTAGE OF STENOSIS, HAD A LITTLE ACUTE ANGLE AND A LITTLE BIFURCATING. THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE. THERE WAS NO EXCESSIVE FORCE USED DURING INSERTION. THERE WAS A DIFFICULTY THAT REQUIRED THAT ALL CONCOMITANT PRODUCTS BE REMOVED TOGETHER. T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9591569 ↗
Other Catheter for crossing total occlusions devices
- Crosser iQ XCTO146Bard Peripheral Vascular, Inc. · Catheter for crossing total occlusions157 reports
- Approach G50791Cook Incorporated · Catheter for crossing total occlusions2 recalls15 reports
- Approach G50792Cook Incorporated · Catheter for crossing total occlusions2 recalls7 reports
- Approach G50787Cook Incorporated · Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50788Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50789Cook Incorporated · Catheter for crossing total occlusions2 recalls0 reports
- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page