BRITE TIP 401911MRecalls & reported problems
Cordis US Corp. · SI 9F BRITE TIP SHEATH 11CM · Class 2
Data updated Oct 13, 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 10705032000437), received between Sep 18, 2020 and Sep 18, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE TIP OF THE 9F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) BECAME DETACHED DURING PROCEDURE. THE SHEATH WAS INSERTED IN THE PATIENT AND WAS SEEN DURING THE ANGIOGRAM THAT THE TIP HAD DETACHED ABOUT AN INCH AWAY FROM THE SHEATH ITSELF, BEING HELD BY THE WIRE. THE ENTIRE SHEATH/TIP WAS RETRIEVED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10553113 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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