PRO-PICC® CT MRCTP41028Recalls & reported problems

Medical Components, Inc. · 4FX55CM SINGLE PRO-PICC® CT BASIC CUTDOWN TRAY · Class 2 · Implant

All models of Pro-PICC CT (12)

Data updated Oct 16, 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 00884908118032), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 13, 2024Break; Break
BASILIC VEIN PUNCTURED USING INTRODUCER NEEDLE UNDER U/S GUIDANCE-GOOD BLOOD FLOW THROUGH NEEDLE. ATTEMPTED TO PASS GUIDEWIRE VIA NEEDLE, BUT EXPERIENCED RESISTANCE. UNABLE TO WITHDRAW GUIDEWIRE. FLUOROSCOPY OF PATIENT'S ARM-TIP OF GUIDEWIRE APPEARED KNOTTED. ATTEMPTS TO MANIPULATE WIRE UNDER FLUOROSCOPIC GUIDANCE UNSUCCESSFUL. ATTEMPTS TO UNTANGLE KNOW USING 4F DILATOR UNSUCCESSFUL. THE PATIENT HAD TO GO TO THEATRE.
Patient problems: Foreign Body In Patient
MAUDE report 20923799 ↗

Device details

UDI-DI	`00884908118032`
Brand	PRO-PICC® CT
Model	MRCTP41028
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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