VISTA BRITE TIP 511040PRecalls & reported problems
Cordis Corporation · 10F-STR 80CM · Class 2
All models of VISTA BRITE TIP (26)
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 20705032010495), received between Oct 3, 2022 and Oct 3, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, AN UNKNOWN OPTEASE WAS UNABLE TO BE RETRACTED TO A 10F STRAIGHT VISTA BRITE TIP GUIDING CATHETER. THEREFORE, AN UNKNOWN SNARE WAS PUSHED TO CHANGE THE POSITION OF CATCH, BUT THE VISTA BRITE TIP CATHETER AND THE UNKNOWN OPTEASE DID NOT RELEASED. THE PHYSICIAN RETRACTED THE UNKNOWN SNARE BY PUSHING THE VISTA BRITE TIP CATHETER. TO REMOVE THE OPTEASE, THE PHYSICIAN DAMAGED THE DISTAL TIP AS INTEND. THE DISTAL TIP RELEASED, AND THE TIP WAS CAUGHT ON THE UNKNOWN SNARE AND THE DEVICES WERE REMOVED TOGETHER. THE OPTEASE WAS SUCCESSFULLY REMOVED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN GUESSES THAT THE UNKNOWN OPTEASE HOOK BITE INTO THE GUIDING TIP AND WAS CAUGHT, SO IT MAY NOT HAVE BEEN PULLED IN. THE PRODUCT WAS STORED, HANDLED, AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THE DEVICE WAS NOT KINK OR BEND AT ANY TIME. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: DURING VISUAL ANALYSIS OF THE DEVICE, THE BRITE TIP OF THE STRAIGHT VISTA WAS OBSERVED RIPPED OFF FROM THE UNIT, CAUGHT AMONG THE OPTEASE AND THE SNARE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15534013 ↗
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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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