BRITE TIP 401805MRecalls & reported problems
Cordis US Corp. · SI BRITE TIP SHEATH F8 5.5 CM · Class 2
All models of BRITE TIP (20)
Data updated Oct 16, 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 10705032000369), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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 16, 2026.
Most reported problems
Device problems
- Contamination of Device Ingredient or Reagent1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
AS REPORTED, THE USERS RAN INTO AN ISSUE WITH AN 8F 5.5CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) DURING A DECLOT CASE WHERE UPON INSERTING THE BRITE TIP INTO THE PATIENTS FISTULA, AND PULLING OUT THE INNER STYLET, THE VALVE WAS FAULTY, AND BLOOD CAME RUSHING OUT. THE VALVE WAS DEFINITELY DAMAGED BUT WAS NOT NOTICED UNTIL INSERTION. THEY IMMEDIATELY JUST REPLACED IT FOR ANOTHER SHEATH (UNKNOWN). THE HUB LEAKAGE/HUB CRACK WAS NOTED WHILE INSERTING THE SHEALTH AND REMOVING THE INNER DILATOR PORTION. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT. RESTERILIZED. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB AND IF SO WHERE ANY ANOMALIES NOTED AT THIS TIME. THE DEVICE WAS PREPPED FOLLOWING IFU INSTRUCTIONS. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. AS PER THE PRODUCT ANALYSIS ,THE HEMOSTASIS VALVE/HUB WAS RECEIVED RIPPED/ TORN AND MOVED FROM ITS ORIGINAL POSITION INSIDE THE HUB OF THE CANNULA. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 12126635 ↗
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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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