PowerPICC Provena S1275108FD1Recalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741154751), received between Feb 7, 2019 and Jan 20, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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

Adverse Event Without Identified Device or Use Problem3
Entrapment of Device1

Patient problems

Thrombosis3
Foreign Body In Patient1

Recent adverse event reports

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

InjuryJan 20, 2021Entrapment of Device
IT WAS REPORTED ON JANUARY 26TH, STAFF PERFORMED AN OVER THE WIRE PLACEMENT, REMOVING A SINGLE LUMEN AND REPLACING WITH A DOUBLE LUMEN. CHEST X-RAY CONFIRMED RETAINED 3CG STYLET. FACILITY STATED THEY DO NOT INTEND TO RETRIEVE THE SYTLET DUE TO THE PATIENT'S CONDITION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 11203023 ↗
InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem
THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1275108FD1. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD OF THREE DEVICES.
Patient problems: Thrombosis
MAUDE report 8318964 ↗
InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem
THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1275108FD1. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF THREE DEVICES.
Patient problems: Thrombosis
MAUDE report 8318961 ↗
InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem
THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1275108FD1. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF THREE DEVICES.
Patient problems: Thrombosis
MAUDE report 8318958 ↗

Device details

UDI-DI	`00801741154751`
Brand	PowerPICC Provena
Model	S1275108FD1
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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