PowerPICC CK000509Recalls & 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: 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 00801741101038), received between Dec 4, 2019 and Jan 30, 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation2
Backflow1
Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Pain1

Recent adverse event reports

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

MalfunctionJan 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED, KINKED PICC AT APPROXIMATELY THE 4CM MARK. CATHETER PLACED (B)(6) 2024. TOTAL CATHETER LENGTH IS 43CM WITH 1CM EXIT SITE MARKINGS. STATLOCK USED TO STABILIZE DEVICE. DWELL TIME: 31 DAYS. INTERVENTION: PULLED BACK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277431 ↗
MalfunctionOct 18, 2024Backflow; Backflow
IT WAS REPORTED BY THE CUSTOMER, IV CONSULT CAME IN TO ASSESS NO BLOOD RETURN ON A 3L PICC. CAPS WERE CHANGED ON ALL THREE LUMENS. HOWEVER, BLOOD REFLUX IN THE WHITE LUMEN AND CAP. THIS WAS NOTED WITHIN MINUTES AFTER CHANGING THE CAP, PULSATILE FLUSHING WITH 10ML, CLAMPING, AND REMOVING THE SYRINGE. THIS ONLY OCCURRED WITH THE WHITE LUMEN. THE PICC WAS PLACED 8.25. THERE WERE NO OTHER ITEMS THAT STOOD OUT THAT MAY HAVE CONTRIBUTED TO THIS FAIL, I.E. KINK IN THE OR MALFUNCTION OF THE CLAMP. THE DEVICE WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20484361 ↗
MalfunctionDec 4, 2019Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED LINE WAS PLACED IN THE RIGHT BASILIC. IT WAS STATED THE PATIENT COMPLAINED OF EXTREME PAIN IN ARM WHEN A CERTAIN LUMEN WAS BEING FLUSHED. LINE WAS REMOVED AND APPEARED TO BE CRIMPED AT TWO DIFFERENT SPOTS.
Patient problems: Pain
MAUDE report 9411402 ↗

Device details

UDI-DI	`00801741101038`
Brand	PowerPICC
Model	CK000509
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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