BRITE TIP 401645MRecalls & reported problems
Cordis US Corp. · SI BRITE TIP 6F 45CM STR · Class 2
All models of BRITE TIP (20)
Data updated Oct 16, 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 10705032000260), received between Mar 24, 2020 and Apr 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, UPON UNPACKING, THE 6F 45CM BRITE TIP SHEATH INTRODUCER WAS FOUND DEFECTED. PER THE TWO IMAGES PROVIDED, THERE APPEARS TO BE A DARK-COLORED, NON-MOVEABLE PARTICLE ON THE CANNULA. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS NOT USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921431 ↗MalfunctionMar 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AT THE START OF A GONADAL PHLEBOGRAPHY, THE 6F 45CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) WAS REMOVED FROM THE PACKAGING AND IT WAS VISUALIZED THAT THE ¿KEY¿ OF THE INTRODUCER AND THE WHITE CARDBOARD IN THE PACKAGING HAD REMAINED LIKE GLUE. THEREFORE, THE DOCTOR PREFERRED NOT TO USE THE DEVICE AND COMPLETE THE PROCEDURE WITH AN UNKNOWN CSI. THERE WAS NO REPORTED PATIENT INJURY. THE IMAGES FOR THE REPORTED DEVICE WAS PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9872052 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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