PowerPICC® Catheter 3276155Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC Catheter 6F Dual-Lumen Radiology Basic Kit (55 cm) · Class 2 · Implant

Data updated Oct 18, 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 00801741028014), received between Apr 3, 2019 and Nov 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 18, 2026.

Most reported problems

Device problems

Defective Component1
Detachment of Device or Device Component1
Failure to Advance1
Material Deformation1
Peeled/Delaminated1
Physical Resistance/Sticking1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionNov 4, 2022Defective Component; Material Deformation; Defective Component; Material Deformation
IT WAS REPORTED THAT DURING CATHETER INSERTION, THE CATHETER WAS FOUND DIFFICULT TO INSERT. AFTER REMOVAL, THE WIRE AND CATHETER WERE FOUND DEFORMED. PATIENT STATUS/ INTERVENTION: CHANGE NEW WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15736122 ↗
MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK CANNOT USE. PATIENT STATUS/INTERVENTION: FINE. ADD TO DESCRIPTION: 09/28/2022 - THE STALOCK ON THE RETURNED SAMPLE WAS OBSERVED TO BE DETACHED FROM THE PAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15550404 ↗
MalfunctionJun 9, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INTRODUCER CANNOT BE SMOOTHLY INSERTED INTO THE BLOOD VESSEL, AND AFTER REMOVAL, THE END BIFURCATION IS UNUSABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10134644 ↗
MalfunctionApr 3, 2019Failure to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING INSERTION, IT IS DIFFICULT TO ADVANCE PICC THROUGH WIRE, (THE USER FELT THE PICC TIP STUCK INSIDE THE PATIENT. THEN USE ANOTHER PICC TO COMPLETE). ON 03/12/2019 - RETURNED WIRE IS KINKED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8478952 ↗

Device details

UDI-DI	`00801741028014`
Brand	PowerPICC® Catheter
Model	3276155
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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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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