NA P1PIC1.9-CRecalls & reported problems

Footprint Medical, Inc. · 1.9Fr Single Lumen Polyurethane PIC Catheter · 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 00858778006065), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Pleural Effusion1

Recent adverse event reports

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

InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE DAY AFTER PLACEMENT OF THE PICC LINE, THE PATIENT NEEDED MORE OXYGEN AND EXPERIENCED SWELLING OF THE NECK. XRAY OF THE PATIENT INDICATED THE CATHETER WAS MALPOSITIONED. PLEURAL EFFUSION WAS REPORTED AND THE LINE WAS REMOVED. THE PATIENT SYMPTOMS REPORTEDLY RESOLVED WITHIN ONE DAY OF PICC REMOVAL.
Patient problems: Pleural Effusion
MAUDE report 15631967 ↗

Device details

UDI-DI	`00858778006065`
Brand	NA
Model	P1PIC1.9-C
Company	Footprint Medical, Inc.
Product code	LJS · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Class	Class 2
FDA submission	K130507
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	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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