Langston® dual lumen catheter 5550Recalls & reported problems
Vascular Solutions, Inc. · Each LANGSTON dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients. · Class 2
Data updated Oct 18, 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 M20655500), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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 18, 2026.
Most reported problems
Device problems
- Separation Problem1
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.
MalfunctionJun 12, 2019Separation Problem; Separation Problem
THE INTERNAL AND EXTERNAL CATHETER BECAME DETACHED AT THE HUB. ADDITIONAL INFORMATION RECEIVED 05/13/2019: THERE WAS NOTHING UNUSUAL ABOUT THE HANDLING AND NO PRESSURE INJECTION WAS DONE ON THIS CASE. WE WERE ATTEMPTING TO CROSS A SEVERELY STENOSED VALVE AND IT TOOK ABOUT 30 MINUTES. THE CATHETER SEPARATION WAS NOTICED AT THE MIDDLE OF THE CASE WHEN WE TRIED TO FLUSH THE LUMENS WITH THE MANIFOLD, ONLY MANUAL FLUSH OF THE SIDEARM WAS DONE, IT WAS THEN WE NOTICED BUBBLES AS WE DREW BACK ON THE TUBING TO PURGE THE LINE. WE ALSO NOTICED THAT SALINE WAS DRIPPING BY THE CONNECTION. A DIFFERENT LANGSTON CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8690915 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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