BRITE TIP 401935MRecalls & reported problems
Cordis US Corp. · SI 9F BRITE TIP 35CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000451), received between Mar 19, 2019 and Mar 19, 2019 — classified as 1 injury.
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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHILE REMOVING A 9F BRITE TIP 35CM SHEATH INTRODUCER, IT BROKE OFF IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO LESION CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY. THE VESSEL HAD MODERATE ANGULATION. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT RESTERILIZED. THE SHAFT SEPARATED ABOUT 1CM FROM THE HEMOSTATIC HUB. NO ANOMALIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. NO ANOMALIES WERE NOTED DURING PREP. THERE WAS VERY MINOR RESISTANCE DURING THE SHEATH REMOVAL WHEN THE DEVICE FAILED. THERE WAS NOT ANY RESISTANCE DURING THE WITHDRAWAL OF ANY DEVICES THROUGH THE SHEATH. THERE WAS A VERY MINOR AMOUNT OF RESISTANCE PRIOR TO FAILURE, IT WAS WITHIN THE EXPECTED AMOUNT OF FORCE TO USE WHEN REMOVING A SHEATH. THE SHEATH MAY HAVE BEEN KINKED OR TORQUED PRIOR TO THE SEPARATION, A FIGURE EIGHT HEMOSTATIC SUTURE WAS PLACED PRIOR TO THE REMOVAL OF THE SHEATH. THE SUTURE WAS TIED, BUT NOT CINCHED DOWN. THE SHEATH WAS IN PLACE FOR 1.5 HOURS. AN OBTURATOR WAS NOT USED IN THE SHEATH AFTER THE PROCEDURE. THE SHEATH WAS NOT USED FOR ANY INFUSIONS. AN ATTEMPT WAS MADE TO CUT DOWN TO THE VESSEL AND REMOVE THE DEVICE. IT WAS
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8432369 ↗
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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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