Pro-PICC® CT MR17034102Recalls & reported problems

Medical Components, Inc. · 4F X 55CM SINGLE LUMEN Pro-PICC® CT BASIC LONG WIRE SET · Class 2 · Implant

All models of Pro-PICC CT (12)

Data updated Oct 16, 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 00884908033076), received between Mar 14, 2018 and Jan 18, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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

Device problems

Leak/Splash2
Appropriate Device Problem Term/Code Not Available1
Break1

Patient problems

No Known Impact Or Consequence To Patient2
No Clinical Signs, Symptoms or Conditions1
Pain1

Recent adverse event reports

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

MalfunctionJan 18, 2021Break; Break
NEXT DAY AFTER INSERTION IT WAS NOT POSSIBLE TO ASPIRATE OR FLUSH THE PICC. BY CONTRAST MEDIUM ADMINISTRATION IN RADIOLOGY IT WAS SEEN THAT THE PICC WAS SEPARATED IN THE BODY. THE PICC WAS REMOVED TRANSFEMORALLY AND VIA THE BASAL VEIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11188646 ↗
MalfunctionDec 28, 2020Leak/Splash; Leak/Splash
THE PICC WAS BLOCKED AND THE NURSE APPLIED ACTILYSE. AFTER THE APPLICATION, THE PATIENT HAD PAIN IN THE PICC ARM. UNDER CONTRAST MEDIUM, THE LEAK AFTER THE WING IN THE PICC LUMEN WAS SEEN. THE PICC WAS PULLED AND A NEW PICC IMPLANTED.
Patient problems: Pain
MAUDE report 11077854 ↗
MalfunctionDec 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
LUMEN BURST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8180680 ↗
MalfunctionMar 14, 2018Leak/Splash; Leak/Splash
PICC LEAKS AT THE JUNCTION OF TUBING TO THE PURPLE WING. WHEN ATTACHING THE INFUSION WITH NACL, FLUID EXITS AT THE END OF THE TUBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7337584 ↗

Device details

UDI-DI	`00884908033076`
Brand	Pro-PICC® CT
Model	MR17034102
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	Not in Commercial Distribution
Record updated	Feb 19, 2021

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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