PowerPICC CK000960Recalls & 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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741200977), received between May 9, 2023 and Jul 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Contamination /Decontamination Problem1
Dull, Blunt1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Perforation of Vessels1

Recent adverse event reports

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

MalfunctionJul 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY CUSTOMER THAT DOUBLE LUMEN PICC REPLACED. ONE OF THE DOUBLE LUMENS WAS COMPLETELY BLOCKED BY TUBING THAT WAS LODGED AND STUCK IN THE LUMEN. BECAUSE OF THIS, NO NEW TUBING OR NEEDLELESS CONNECTOR WAS ABOUT TO BE REPLACED. TUBING WAS LEFT OPEN TO AIR CAUSING THE ENTIRE LINE NEEDING TO BE REPLACED IN ORDER TO BE USED. NO DEFECT WAS NOTED ON INSERTION AND PLACEMENT ON PRODUCT. THE ISSUE HAPPENED AFTER PLACEMENT AND VERIFICATION OF OK TO USE. NO IMPACT/HARM TO PATIENT KNOWN. PATIENT RECEIVED ALL MEDICATIONS NEEDED AND WE WERE ABLE TO FIX THE LINE BEFORE NEXT MEDICATION ADMINISTRATION ORDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577762 ↗
MalfunctionMay 9, 2023Dull, Blunt; Dull, Blunt
IT WAS REPORTED BY THE CUSTOMER THAT "NEEDLE IS VERY DULL. HAVING TO PUSH SO HARD TO ACCESS VEINS AND THEY ARE BACK WALLING THE VESSEL. HAVE NOTICED SIGNIFICANT CHANGE IN NEEDLE SHARPNESS."
Patient problems: Perforation of Vessels
MAUDE report 16898621 ↗

Device details

UDI-DI	`00801741200977`
Brand	PowerPICC
Model	CK000960
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
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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