Pro-Line® CT MRCTC72001Recalls & reported problems

Medical Components, Inc. · 7F X 60CM DUAL Pro-Line® CT BASIC IR SET · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908097177), received between May 6, 2024 and May 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Insufficient Device Problem Information1

Patient problems

Extravasation1
Swelling/ Edema1

Recent adverse event reports

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

InjuryMay 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WITH NEW R NECK TISSUE ISCHEMIA ABOVE HICKMAN WITH CONCERN FOR PRESSOR EXTRAVASATION. PATIENT HAS R IJ HICKMAN AND PERMACATH PLACED BY IR ON THURS (REDACTED DATE). OVER WEEKEND AND INTO BEGINNING OF FOLLOWING WEEK PATIENT NOTED TO HAVE LARGE SWINGS IN PRESSOR REQUIREMENTS. HE ALSO STATED HAVING BRADY ARRYTHMIAS. ON TUES (REDACTED DATE) PATIENT NOTE TO HAVE MOD AMT OF DRAINAGE COMING FROM OLD R IJ QUINTON SITE ABOVE THE HICKMAN. ON THE MORNING OF (REDACTED DATE) UPON EXAM PATIENT NOTED TO HAVE INCREASED EDEMA AND NEW TISSUE NECROSIS. CT SOFT TISSUE NECK AND CHEST OBTAINED. R NECK SOFT TISSUE NOTED TO HAVE SUBCUTANEOUS GAS. HICKMAN DID APPEAR IN CORRECT PLACE. EGS CONSULTED, CONCERNED FOR PRESSOR EXTRAVASATION TO R NECK WHICH PROBABLY HAS BEEN HAPPENING OVCER TIME AS SEEING LATE SIGNS OF EXTRAVASATION. HICKMAN ALSO VISUALIZED THROUGH HOLE OF OLD QUINTON SITE. NEW FEMORAL IJ TLC PLACED AND WHEN PRESSORS CHANGED TO TLC REQUIREMENTS SIGNIFICANTLY DECREASED. IR CONSULTED AND HICKMAN AND PERMACATH REMOVED AT BEDSIDE AND BROUGHT TO (REDACTED NAME) OFFICE.
Patient problems: Extravasation; Swelling/ Edema
MAUDE report 19249284 ↗

Device details

UDI-DI	`00884908097177`
Brand	Pro-Line® CT
Model	MRCTC72001
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	Sep 19, 2024

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

A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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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