CORDIS 67000300Recalls & reported problems
Cordis US Corp. · 6F .070 JL3.5 SH 100CM · Class 2
Data updated Oct 16, 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 20705032019870), received between May 24, 2018 and May 24, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K021593); they may or may not involve this specific model.
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 Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2018Detachment Of Device Component; Detachment Of Device Component
DURING USE DURING A CARDIAC CATHETERIZATION, IT WAS REPORTED THAT THE TIP OF THE VISTA BRITE TIP GUIDING CATHETER SEPARATED INSIDE THE PATIENT. THE TIP WAS RETRIEVED WITH A HANDLE AND WAS REMOVED, AN AORTOGRAM WAS PERFORMED TO THE PATIENT TO VERIFY THAT EVERYTHING IS FINE. THE PATIENT LEFT IN PERFECT CONDITIONS. THE PROCEDURE WAS COMPLETED. THE STORAGE OF THE SUPPLIES ARE IN GOOD STORAGE CONDITIONS.
Patient problems: Foreign Body In Patient
MAUDE report 7542141 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021593. One submission often covers many models, so check the product and lot details in each record.
- Z-1330-2025 · Feb 7, 2025 · Open, ClassifiedVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices
- Z-1198-2019 · Feb 7, 2019 · TerminatedCordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into
- Z-0434-05 · Dec 7, 2004 · TerminatedVISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
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- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 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 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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