Vascu-Line® MR28013121Recalls & reported problems
Medical Components, Inc. · 3F X 60CM SINGLE LUMEN Vascu-Line® W/ CUFF SET (CUFF 2CM FROM HUB) · Class 2 · Implant
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 00884908094855), received between Jul 26, 2021 and Jul 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Leak/Splash1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2021Fracture; Leak/Splash; Fracture; Leak/Splash
FRACTURED CENTRAL LINE - 3 FRENCH CUFFED PICC. LOCATION OF FRACTURE: CONNECTION WHERE CLEAR PORTION MEETS WHITE PORTION JUST BEFORE CAP CONNECTION. LOCATION OF LINE: RIGHT BASILIC. PARENTS PERFORMED THE 4 "C" CLAMP BETWEEN FRACTURE AND INSERTION SITE, CLEAN WITH CHLORHEXIDINE AND COVER WITH STERILE OCCLUSIVE DRESSING. REQUIRED A REWIRE UNDER GENERAL ANESTHESIA.
Patient problems: Failure of Implant
MAUDE report 12224573 ↗
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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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