Langston® dual lumen catheter 5540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M20655400), received between Sep 28, 2017 and Dec 7, 2017 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2017Detachment Of Device Component; Detachment Of Device Component

  LANGSTON CATHETER WAS USED THROUGH A 6 FR SHEATH IN THE RADIAL ARTERY. PATIENT DEVELOPED SEVERE ARTERIAL SPASM DURING REMOVAL OF THE LANGSTON. LANGSTON BECAME LOCKED IN THE RADIAL ARTERY IN THE FOREARM AREA DUE TO THE SEVERE SPASM. SEVERAL ATTEMPTS TO REMOVE IT WERE MADE. PATIENT WAS ALSO GIVEN NITRO, VERSED AND FENTANYL TO TRY TO REDUCE THE SPASM. UPON FINAL ATTEMPT TO REMOVE THE LANGSTON, THE CATHETER BROKE AND THE TIP REMAINED LODGED IN THE RADIAL ARTERY. PATIENT WAS SUBSEQUENTLY TRANSFERRED TO SURGERY FOR FOREIGN BODY REMOVAL.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7095640 ↗
• MalfunctionNov 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS NOT A CRACK IN THE CATHETER. THERE WAS A BLUE PIECE PROTRUDING FROM THE CATHETER AND RIGHT WHERE THEY APPEAR TO BE SEPERATED THERE WAS BLOOD COMING OUT FROM IN -BETWEEN THE TWO CATHETER PIECES. NO ADVERSE PROBLEMS OCCURED. THE CATHETER WAS NOT SAVED. MDR 2134812-2017-00091 IS ALSO RELATED TO THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7018394 ↗
• MalfunctionNov 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE EXPERIENCED AIR DRAWING BACK FROM THE ENGAGED CATHETER WHILE FLUSHING AND PREPPING TO ZERO THE LINE. AN UNUSUAL BLUE SEGMENT OF CATHETER WAS NOTED TO BE EXTENDING FROM THE YELLOW SEGMENT OF THE CATHETER. THE CATHETER WAS REMOVED AND ANOTHER LANGSTON WAS USED SUCCESSFULLY TO COMPLETE THE CASE WITHOUT INCIDENT. NO PATIENT IMPACT OR INJURY REPORTED. MDR 2134812-2017-00090 IS ASSOCIATED TO THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7018110 ↗
• MalfunctionSep 28, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING THE LV POWER INJECTION, THE YELLOW TUBING AT THE HUB OF THE CATHETER FRACTURED. 900 PSI WAS USED FOR THE INJECTION. ANOTHER LANGSTON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. REFERENCE MDR 2134812-2017-00074 FOR ASSOCIATED REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900588 ↗