PowerPICC Catheter 3386335Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC Catheter 6F Radiology Basic Tray (Triple-Lumen) (135cm Nitinol Guidewire) · Class 2 · Implant

All models of PowerPICC Catheter (33)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028304), received between Nov 8, 2022 and Apr 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

Reports received per month

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

Most reported problems

Device problems

Fluid/Blood Leak2
Defective Component1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, ¿PICC INSTALLED WITHOUT INCIDENT, HOWEVER, IMMEDIATELY AFTER PERMEABILIZING THE LUMENS WITH PHYSIOLOGICAL SALINE, SERUM LEAKAGE IS VISUALIZED AT THE JUNCTION OF THE LUMENS TO THE CATHETER, SO IT IS REMOVED AND ANOTHER PICC IS INSTALLED. NO PATIENT INJURY.¿ NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19094163 ↗
MalfunctionNov 8, 2022Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED DEVICE PRESENTS DAMAGE TO ITS CATHETER SEGMENT AT 40 CM. THE DEVICE WAS NOT USED IN THE PATIENT, THE EVENT OCCURRED IN THE INSTALLATION PROCESS, FOR WHICH ANOTHER CATHETER OF THE SAME REFERENCE HAD TO BE OPENED, WITHOUT PROBLEMS. ADDITIONAL INFORMATION RECEIVED 02 NOV 2022: WAS THE DEVIATION IDENTIFIED WHEN OPENING THE PACKAGE? THE PRODUCT IS VERIFIED DEFECTIVE AT THE MOMENT OF OPENING THE PACKAGING VISUALLY. WAS THE CATHETER INFUSED WITH SALINE PRIOR TO DETECTION? NO, AS THIS WAS VISUALLY VERIFIED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15756955 ↗

Device details

UDI-DI	`00801741028304`
Brand	PowerPICC Catheter
Model	3386335
Company	Bard Access Systems, 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	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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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