PowerPICC Provena CK000883Recalls & reported problems

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

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: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741188800), received between Nov 18, 2021 and Jun 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 reports).

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.

Recalls naming this device

May 21, 2026Class IIOpen, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2664-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Material Frayed3
Loss of or Failure to Bond1

Patient problems

No Clinical Signs, Symptoms or Conditions3
Insufficient Information1

Recent adverse event reports

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

MalfunctionJun 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DRESSINGS SEEM TO BE NOT ADHERING AND THE GEL SEEMS TO BE MELTING AWAY AND DISCOLORING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17089781 ↗
MalfunctionNov 18, 2021Material Frayed; Material Frayed
IT WAS REPORTED "SHERLOCK WIRE BROKE ON THE COPPER SECTION WITH THE INTERNAL WIRE STILL INTACT." IT WAS STATED THERE WAS NO INJURY. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12838188 ↗
MalfunctionNov 18, 2021Material Frayed; Material Frayed
IT WAS REPORTED "THIS SHERLOCK WIRE ON THIS PICC COMPLETELY BROKE AND WAS DISCOVERED LODGED WITHIN IN THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12838024 ↗
MalfunctionNov 18, 2021Material Frayed; Material Frayed
IT WAS REPORTED "SHERLOCK WIRES BROKE ON THE COPPER SECTION WITH THE INTERNAL WIRE STILL INTACT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12837987 ↗

Device details

UDI-DI	`00801741188800`
Brand	PowerPICC Provena
Model	CK000883
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 · 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.

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