LANGSTON IPN913561Recalls & reported problems
Teleflex Incorporated · Langston V2 6F Multipurpose · Class 2
All models of LANGSTON (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156100537), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 31, 2020Class ITerminated
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-0113-2021 · Root cause: Process control · Recall details · FDA record ↗
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.
MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: PERFORMING AORTIC VALVE STUDY USING A 6F RADIAL ACCESS. AORTIC PORT WOULD PERSISTENTLY ASPIRATE AIR AND BLOOD WHEN IN BODY. BLOOD LEAKAGE WAS NOTED AT THE HUB. NO INJECTIONS PERFORMED, POWER OR OTHERWISE. UPON REMOVAL OF THE CATHETER THE INNER CATHETER BECAME DETACHED FROM THE OUTER LAYER OF THE CATHETER LUMEN. ALL OF THE CATHETER WAS RETRIEVED FROM THE PATIENT WITHOUT INCIDENT. IT WAS NOT COMPLETELY DETACHED AND CAME OUT MANUALLY OVER A WIRE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11453010 ↗
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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 · each recall links to the FDA recall notice
- 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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