PowerPICC Provena CK000987Recalls & 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: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741216015), received between Jul 11, 2023 and May 7, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Material Deformation2
Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 7, 2025Material Deformation; Material Deformation
IT WAS REPORTED, INSERTED A PICC A WEEK AGO IN PATIENT. VAT RN WAS TROUBLESHOOTING WHAT APPEARED TO BE AN OCCLUDED LINE. PATIENT WAS GIVEN 2 DOSES OF CATHFLO AND REPLACED WITH A MIDLINE AFTER NOT SUCCESSFUL IN SAVING THE LINE. THE LINE HAD BEEN INSERTED JUST BEFORE ZERO MARK AND AT 3.5 MARK NOTICED A BEND. THE BEND APPEARED TO BE A WEAKEN AREA OF THE CATHETER BUT IT WAS NOT FRACTURED IN HALF. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21978636 ↗
MalfunctionApr 16, 2024Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT TRANSITION FROM THE PEEL AWAY SHEATH WILL ROLL UP ON TISSUE. IT SPLITS IT AND HAVE TO GET A NEW ONE. IT IS SOMETHING WITH THE TRANSITION THAT CATCHES. HAVE TO GO BACK IN AND KNICK A SECOND TIME TO TRY TO ADVANCE THE INTRODUCER. THERE WAS NO ADVERSE OUTCOME OR SERIOUS INJURY TO THE PATIENT OR HEALTHCARE PROVIDER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114825 ↗
MalfunctionJul 11, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER THAT WHEN CUSTOMER WAS INSERTING A 4FR DUAL LUMEN PROVENA PICC AND KEPT FEELING RESISTANCE. SHE PULLED THE PICC BACK OUT AND NOTICED THAT THE WIRE WAS COMPLETELY BENT INSIDE THE PICC. SHE INSERTED A NEW PICC. NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17297579 ↗

Device details

UDI-DI	`00801741216015`
Brand	PowerPICC Provena
Model	CK000987
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 Catheter 3275118
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
272 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
Page last rebuilt: Oct 18, 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