Vascu-Line® MR28013151Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908094862), received between Mar 26, 2019 and May 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Break; Break

  VASCU-LINE CATHETER 3FR BROKE. IT BROKE AT THE LEVEL OF THE CLEAR EXTENSION NEAR THE HUB (WHERE WE WOULD ATTACH A NEEDLELESS CAP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14412141 ↗
• MalfunctionFeb 9, 2022Leak/Splash; Leak/Splash

  A (B)(6) PATIENT DEPENDENT ON TPN. AT THE END OF PERFUSION, THE MOTHER IRRIGATED THE CATHETER WITH A SALINE SOLUTION. THE CATHETER WAS LEAKING AT THE JUNCTION OF THE BASE OF THE WHITE HUB AND THE EXTENSION. PATIENT COULD NOT RECEIVE HIS PARENTERAL NUTRITION (OF THE DAY). FASTING FOR LESS THAN 24 HOURS. THE MOTHER WAS INSTRUCTED TO CLAMP THE CATHETER BETWEEN THE INSERTION SITE AND THE LEAK. APPLY DRESSING TO PROTECT. DO NOT USE CATHETER UNTIL REPLACED. PUT ON EMERGENCY LIST FOR REPLACEMENT UNDER GENERAL ANESTHESIA. PIV INSERTED NEXT AM BY DR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500361 ↗
• MalfunctionMar 26, 2019Break; Break

  CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452763 ↗