Vascu-PICC® MR17011101Recalls & reported problems

Medical Components, Inc. · 1.9F X 50CM SINGLE LUMEN Vascu-PICC® BASIC SET · Class 2 · Implant

All models of VASCU-PICC (22)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908032659), received between Apr 17, 2017 and Jul 17, 2020 — classified as 4 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 18, 2026.

Most reported problems

Device problems

Break2
Leak/Splash2
Hole In Material1
Occlusion Within Device1

Patient problems

No Known Impact Or Consequence To Patient4

Recent adverse event reports

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

MalfunctionJul 17, 2020Break; Break
PICC LINE IN PATIENT. LINE BROKE AT WING CONNECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10290840 ↗
MalfunctionSep 18, 2019Leak/Splash; Leak/Splash
AFTER THE CATHETER WAS INSERTED THE GUIDEWIRE WAS REMOVED AND THE CATHETER SALINIZED. IT WAS IMMEDIATELY NOTICED THAT THE CATHETER LUMEN HAD RUPTURED NEAR THE SUTURE WINGS. CATHETER WAS REMOVED AND REPLACED WITH ANOTHER. NO ADVERSE CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9083520 ↗
MalfunctionMar 29, 2019Break; Break
A LEAK IN THE LUMEN CLOSE TO THE INSERTION SITE WAS NOTED WHEN SERUM WAS INSERTED INTO THE CATHETER. CATHETER WAS REPLACED WITH ANOTHER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8464132 ↗
MalfunctionApr 17, 2017Hole In Material; Leak/Splash; Occlusion Within Device; Leak/Splash
LINE "OCCLUDED" - WHEN LINE WAS HEPARIN FLUSHED, NOTED TO BE LEAKING FROM INSERTION SITE. LINE REMOVED BY PROVIDER AND NOTED TO HAVE BREAK/HOLE NEAR THE 1 CM MARK WHEN FLUSHED AND NO FLUID FLUSHING THROUGH TIP OF CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6496893 ↗

Device details

UDI-DI	`00884908032659`
Brand	Vascu-PICC®
Model	MR17011101
Company	Medical Components, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 15, 2022

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

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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