Langston® dual lumen catheter 5515Recalls & reported problems
Vascular Solutions, Inc. · 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 M20655150), received between Mar 27, 2017 and Mar 27, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of 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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- 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.
MalfunctionMar 27, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component
DURING CARDIAC CATHETERIZATION PROCEDURE, UPON PULLBACK OF THE WIRE, A SNAPPING WAS FELT. THE WIRE WAS ABLE TO BE PULLED COMPLETELY OUT, HOWEVER, NOTED THAT THE DUAL LUMEN CATHETER HAD SNAPPED AT THE NECK AREA. SOME PIECES HAD PROLAPSED WITHIN THE CATHETER WHILE OTHER PIECES WERE RETAINED WITHIN THE LONG SHEATH. UPON FURTHER EXAMINATION, ALL PIECES OF THE CATHETER WERE FOUND. IN ADDITION, FLUOROSCOPY PROCEDURES DONE WHICH DID NOT IDENTIFY ANY RETAINED FRAGMENTS IN THE PATIENT. NO ADVERSE OUTCOME TO THE PATIENT. PT HAD EXTREME TORTUOSITY AND SEVERE CALCIFICATION OF BILATERAL ILIAC ARTERIES AND ALSO ENTIRE AORTA. PERIPHERAL VASCULAR DISEASE, SEVERE AORTIC STENOSIS AND HISTORY OF 3 VESSEL CABG IN 2008.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6435991 ↗
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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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