PowerPICC CK000739Recalls & reported problems

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

All models of PowerPICC (118)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741139659), received between Feb 1, 2018 and Apr 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination With Biological Material” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Mar 11, 2025Open, Classified
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Device Contamination With Biological Material1
Device Packaging Compromised1
Fluid/Blood Leak1

Patient problems

Extravasation1
No Patient Involvement1

Recent adverse event reports

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

InjuryApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED 3/31: A NEW CATHETER WAS NOT PLACED. COMPLAINANT STATES THE EVENT CAUSED A CLINICALLY SIGNIFICANT DELAY IN TREATMENT BECAUSE IT OCCURRED DURING CHEMOTHERAPY INFUSION.
Patient problems: Extravasation
MAUDE report 21766713 ↗
MalfunctionFeb 1, 2018Device Contamination With Biological Material; Device Packaging Compromised
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE PACKAGING. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7234229 ↗

Device details

UDI-DI	`00801741139659`
Brand	PowerPICC
Model	CK000739
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.

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

Groshong NXT ClearVue Catheter 7617405
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
2 deaths1,708 reports
Groshong NXT ClearVue Catheter 7655405
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
2 deaths1,536 reports
PowerPICC Catheter 3174118
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
1 recall402 reports
L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cm
Argon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
2 recalls245 reports
PowerPICC SOLO2 Catheter 1194108D
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
2 recalls216 reports
Broviac 0600520
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
1 recall265 reports
Groshong® Catheter 7717405
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
279 reports
PowerPICC® Catheters 1174108D
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
1 recall222 reports

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page