BRITE TIP 401735MRecalls & reported problems
Cordis Corporation · SI BRITE TIP 7F 35CM STR · 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 10705032000321), received between Dec 20, 2023 and Dec 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, IT LOOKS LIKE THERE IS SOME SORT OF OINTMENT AT THE TIP INSIDE THE STERILE PACKAGE OF A 7F 35CM BRITE TIP SHEATH INTRODUCER. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED, AND STORED IN THE LAB, PRIOR TO USING. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO PACKAGING DAMAGE NOTED, NO DAMAGE TO THE SHIPPING BOX, TO THE OUTER PRODUCT BOX OR THE INNER PRODUCT POUCH. THE STERILE POUCH WAS NOT RECEIVED OPEN/COMPROMISED AND IT WAS NOT DAMAGED. THE PRODUCT WAS NOT PURPOSELY OPENED IN ANTICIPATION OF USE, AND HAD NOT BEEN RESHELVED. THE DEVICE IS EXPECTED TO BE RETUNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363800 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page